規制実務合意に関するCIS加盟諸国の調整情報センター
00

How to be ready for
TR EAEU 041/2017, including
SDS development under GOST
30333
Reshetar OlgaSenior Expert of Chemical Safety
Department, CIS center2021

TR EAEU 041/2017 State registration timing
If an imported chemical product is a SUBSTANCE
Tonnage for one legal entity (LE) per year

START of state registration (DRAFT Decision)> 1000 t/y
100-1000 t/y

as soon as TR EAEU 041/2017 comes into force(30 November 2022 - at the earliest)
30 November 2024

1-100 t/y

30 November 2026

< 1 t/yAdditional decision (Must be resolve by 30 November 2028)

If an imported chemical product is a MIXTURE
Tonnage for one LE per year
> 1000 t/y

START of state registration (DRAFT Decision)
30 November 2027

100-1000 t/y

30 November 2029

10-100 t/y

30 November 2031

< 1 t/yAdditional decision (Must be resolve by 30 November 2028)

Please note:
1. Timing may be changed by the Decision of EEC and EAEU members
2. Timing is applicable only for state registration
3. SDS under GOST 3033 and labelling under 31340 are required from the date TR EAEU 041/2017
comes into force
CIS Center2

The main steps after the date TR EAEU 041/2017
comes into force
If your produced or exported chemical products which include into the area ofdistribution of TR EAEU 041/2017 follow the next steps

If there is no vertical technical regulation foryour products

Only representative at EAEU territory

If there is a vertical technical regulation foryour products

After the entry into force of the TR EAEU
041/2017 you need to have on products:
a safety data sheet and a warning labeling

Choose the country

Link where you can see the responsible authorized bodies in the EAEU countries
http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/tr/Pages/notified_body.aspx

3Set of documents
Permit state registration

1. Application (form in Appendix No. 5 to TR)
2. Safety data sheet (information according toGOST 30333)
3. Research (test) protocols and (or) 4.
documents with information from theirofficial sources (if any)
4. Information specified in clause 48(notification)
5. Other documents at the choice of theapplicant

Notification state registration

1. Application(form in Appendix No. 5 to TR)
2. Safety data sheet(information according to GOST 30333)
3. Research (test) protocols and (or)documents with information from theirofficial sources (if any)
4. Other documents at the choice of theapplicant

SDS the main document for any kind ofregistration!
4

The SDS under GOST 30333 is notdeveloping for:• minerals in a state of occurrence• finished medicinal products and finished veterinary
medicinal products• finished perfumery and cosmetic products• radiating, nuclear and radioactive substances• finished food products, including biologically
active food additives, food additives and readymade animal feed
• smoking and non-smoking tobacco products• liquids for electronic nicotine delivery systems• products, including medical devices

CIS Center

5The main differences

Information sheet

List of used data sources

CIS Center

Language

6Section content of the RussianSDS№ section

Section content

1.

IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/ UNDERTAKING

2.

HAZARDS IDENTIFICATION

3.

COMPOSITION/INFORMATION ON INGREDIENTS4.

FIRST AID MEASURES

5.

FIRE-FIGHTING MEASURES6.

ACCIDENTAL RELEASE MEASURES

7.

HANDLING AND STORAGE

8.

EXPOSURE CONTROLS/PERSONAL PROTECTION

9.

PHYSICAL AND CHEMICAL PROPERTIES10.

STABILITY AND REACTIVITY

11.

TOXICOLOGICAL INFORMATION12.

ENVIRONMENTAL INFORMATION13.

DISPOSAL CONSIDERATIONS

14.

TRANSPORT INFORMATION

15.

REGULATORY INFORMATION16.

ADDITIONAL INFORMATIONCIS Center

7

Information sheet
The SDS should contain a brief summary/conclusion of the data given, making iteasy even for non-experts in the field to identify all the hazards for the hazardous
substance/mixture• Product name [technical, chemical (according to IUPAC), tradename and synonyms]• Full designation of a standardization document or information andtechnical document and name• Information that identifies the hazard of chemical products• Information about the manufacturer and / or the person
authorized by the manufacturer, importer, supplier, seller, exporter

CIS Center8

1 section Identification
Identification of chemical productsTechnical nameRecommendations and restrictions on the use of chemical products
Information about the manufacturer and/or the person authorized by the manufacturer,
importer, supplier, seller, exporter

The full official name of the organization
Address (postal and legal)
Telephone, including for emergency consultations and time limits
E-mailWebsite (if available)
CIS Center9

2 section GHS label elements(as per GOST 31340-2013)

CIS Center10

3 section Composition(information on ingredients)

CIS Center11

4 section First-aid measures
Observed symptoms• In case of poisoning by inhalation (by inhalation)• When exposed to the skin
• Eye contact• For oral poisoning (if swallowed)

First aid measures for victims• In case of poisoning by inhalation• When exposed to the skin
• Eye contact• In case of oral poisoning• Contraindications

CIS Center12

5 section Fire-fighting measures
General characteristics of fire and explosion hazard (according to GOST 12.1.044)
Indicators of fire and explosion hazard of chemical products (nomenclature ofindicators according to GOST 12.1.044)
Combustion and / or thermal decomposition products and the hazard caused bythem
Recommended extinguishing media
Prohibited extinguishing media
Extinguishing specificity

CIS Center13

6 section Measures to prevent and mitigate
emergency situations and consequences
Measures to prevent harmful effects on people, the environment,buildings, structures, etc. in emergencies and emergencies• General actions required in case of emergency and emergency situations• Personal protective equipment in emergency situations (PPE of emergency teams)

Procedure for the elimination of emergencies and emergencies• Actions in case of leaks, spills, spills (including measures for their elimination andprecautions to ensure environmental protection)• Fire action

CIS Center14

7 section Handling and storage
Safety precautions when handlingchemical products• Engineering safety systems(including the organization oflocal and general ventilation,requirements for electricalequipment, measures toeliminate static electricity)• Environmental protection
measures• Recommendations for safe
handling and transportation

Storage rules for chemicalproducts• Conditions and terms of safe
storage (including the warranty
storage period or warranty
period, shelf life or storage
period); substances andmaterials incompatible duringstorage• Containers and packaging(including materials from which
they are made)• Safety measures and rules ofstorage at home

CIS Center15

8 section Exposure controls andpersonal protective equipment
The parameters of the working area, subject to mandatory control, in accordancewith the requirements of the country (countries) on the market of which theproducts are circulated
Measures to ensure the content of harmful substances in permissible
concentrations

Personal protective equipment for staff• General recommendations• Respiratory protection (types of RPE)
• Protective equipment (classification by purpose depending on protective properties and designation)(overalls, safety footwear, hand protection, eye protection)• Protective equipment for household use

CIS Center16

9 section
Physical and chemical properties• Physical state (including state of matter)• Colour• Smell• Melting point / freezing point• Boiling point / boiling point / boiling range• Flammability• Upper and lower explosion limits / flammability limits• Flash point• Autoignition temperature• Decomposition temperature• pH• Kinematic viscosity• Solubility• Coefficient of propagation n-octanol / water• Vapor pressure• Density and / or relative density• Relative vapor density• Parameters of solid particles
CIS Center17

10 section Stability and reactivity

Chemical stability (forunstable products,indicate hazardous
decompositionproducts)

Reactivity

CIS CenterConditions to Avoid(Including Hazards
from Contact withIncompatible
Substances andMaterials)

18

11 section Toxicologicalinformation

General characteristics of fire and explosion hazard (according to GOST 12.1.044)
Routes of exposure (inhalation, oral, skin and eye contact)
Affected organs, tissues and systems of a person

Information on health hazards resulting from direct contact with products, as well as theconsequences of these effects (irritant effect on the upper respiratory tract, eyes, skin; skinresorptive and sensitizing effects)

Information about hazardous long-term effects of product exposure on the body (effect on
reproductive function, carcinogenicity, mutagenicity, cumulativeness and other chroniceffects)
Indicators of acute toxicity (LD50 (LD50), route of intake, animal species; LC50 (LC50),exposure time (h), animal species) It is allowed to give indicators obtained by theoretical or
calculated methods

CIS Center19

12 section Ecological information20

13 section Disposal considerationsSafety measures when handling waste generated
during application, storage, transportation

Information about the places and methods ofneutralization, utilization, burial or destruction ofproduct wastes, including containers (packaging)

Recommendations for the disposal of waste
generated during the use of products in everyday life

CIS Center21

14 section Transport information
UN number (UN)Proper shipping and shipping nameApplied modes of transport
Classification of cargo hazard according to GOST 19433
Hazard classification of cargo in accordance with (includingpacking group)
Manipulation signs in accordance with GOST 14192
Emergency cards (for rail, sea and other transportation)

CIS Center22

15 section National legislation
Legislation of the country (countries) on themarket of which the goods are traded(Chemical control laws)
Information about the documentation
regulating the requirements for theprotection of humans and the environment
International conventions and agreements(the Montreal Protocol, the StockholmConvention, etc.)

CIS Center23

16 section
List of data sources used in compiling the safety
data sheet (serial numbers of data sources
should be given in each subsection of the SDS inthe form of references)

CIS Center24List of Official Chemical Information Sources• Global Information Portal of the Economic Organization• Cooperation and Development (OECD) on the properties of chemicals eChemPortal• TOXNET Databases platform• INCHEM platform• Portal of the joint research center European Union ChemAgora• Online information from the Federal Register potentially hazardous chemical and biologicalsubstances• Database of the European Chemicals Agency ECHA
• HSDB database• Database of existing substances OECD
• List of carcinogenic factors of the International Agency for Cancer Research (IARC)• PubChem database• DART database• ECOTOX database• Database of properties of chemical substances GESTIS• United States Toxicology Database substances and registries of diseases• Database of properties of active ingredients of pesticides British University of Hertfordshire PPDB
(Pesticide Properties DataBase)• Information system for emergency services WISER

25

List of Official Chemical Information
Sources part 2• International Chemical Safety Cards ICSC

• Institute of Industrial Safety, Labor Protection and Social partnerships AutomatedDistributed Information Search System (ARIPS) "Hazardous Substances”• RTECS database• CPDB Carcinogenicity Database• Report on Potential Carcinogens prepared by as part of the US National Toxicology
Program (the Report on Carcinogens)• US database, created in the framework of the national toxicology programs(includes information on toxic properties of substances and the ability to cause
long-term effects)• ChemIDplus database• Database Haz-Map• GENE-TOX database• Databank EnviChem• Brief document on the international assessment of chemical substances (CICADS)(Concise International Chemical Assessment Document)• Integrated system containing risk information chemicals, US EPA• US Occupational Safety and Health Agencydatabase
CIS Center26

List of Official ChemicalInformation Sources part 3• Japan database containing classification results Chemical Hazards, J-GHS• European inventory of existing chemicals (EINECS)• Inventory of existing industrial substances in Australia (AICS)• List of existing chemicals in Japan• Register of CAS numbers of chemical abstracts service American Chemical Agency.
• Reaxys database• Chemical SciFinder Structural Search Database Abstract Service (CAS)• Portal for the selection of analogous substances SUBSPORT (Substitution SupportPortal)• OECD software product (QSAR Toolbox) for predicting the properties of a chemical
based on its structures (structure-activity model)• Software product (EMKG-Expo Tool) of the Federal German Institute for
Occupational Safety and Health for the prediction inhalation effects of solid andliquid substances at work location• Software tool (AMBIT) developed by The European Council of the Chemical Industry(CEFIC), for prediction of the hazardous properties of chemicals by structural
analogs, etc.
• A software tool (BIOTS) developed by CEFIC for predictions of theCIS Center
biotransformation potential of chemicals

27

Coordinating Informational Centerof CIS Member States on approximation of regulatory practices

Thank you for your interest!

info@ciscenter.org+ 7 495 128 95 45