Coordinating Informational Centerof CIS Member States on approximation of regulatory practices00

Technical regulation of the Eurasian Economic Union≪On the Safety of Chemical Products≫(TR EAEU 041/2017)

Natalia Druzhinina
CIS Center, Russia

04 February 2021

Content

1. Basic information – 2. How to be ready – 3. Latest Updates2

1. Basic information – 2. How to be ready – 3. Latest Updates

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TR EAEU 041/2017
Adopted on 3 March 2017 by Decision No.19 of the Council of the Eurasian EconomicCommission (EEC)
Establishes the mandatory safety requirements for chemical products in order toprotect the human health and environment and to prevent actions misleading
consumers during chemicals handling→ Safety for human health and environment→ Prevention of misleading information for consumers→ Free circulation in Eurasian Economic Union (EAEU) territory
EAEU member states:
 Republic of Armenia Republic of Belarus Republic of Kazakhstan Republic of Kyrgyzstan
 Russian Federation4

Chapters
TR EAEU
I. Scope of application
041/2017
II. Main definitions
harmonized
III. Chemical product identification ruleswithIV. Rules for the circulation of chemical products on the EAEU market
the GHSV. Requirements for the classification of chemical products
VI. Chemical safety requirements
VII. Requirements for the labelling of chemical products
VIII. Warning labelling requirements
IX. Safety data sheet requirements
X. Ensuring the compliance of chemical products with the requirements of technicalregulations
XI. Notification of new chemical substances
XII. Conformity assessment of chemical products to the requirements of technical regulations
XIII. Labelling of chemical products with a single product circulation mark on the EAEU market
EAC stands forEurasian Conformityor5Scope of application
All chemical products
placed on the market of the Union customs territory as

substance

mixtureDefinitions: Substance – a chemical element and (or) its compounds in the natural state or
obtained by any manufacturing process, including any additive necessary topreserve its stability and any impurity deriving from the process used, butexcluding any solvent which may be separated without affecting the stability of thesubstance or changing its composition (chemical substance is the chemical productin which the percentage of the main component is equal to 80% or more by mass
while the total content of impurities and/or additives is less than 20% by mass) Mixture – a mixture or solution of two or more substances in which they do notreact with each other6

Out of scope
List of exceptions provided in Annex 1 to TR as follows:
1. Chemical products used in scientific research and development
2. Minerals in their natural state of occurrence
3. Medical products and preparations for veterinary use
4. Perfumes and cosmetics
5. Chemical products serving as an ionizing radiation source
6. Food products, incl. biologically active supplements
7. Products in articles which during treatment in the customs territory of the EAEU
do not change their chemical composition and which are not subject todecomposition or oxidation processes, and which do not form dusts, vapours andaerosols containing chemicals that are hazardous to the life and health ofhumans, animals or plants, the environment, or property.
8. Wastes from the production and consumption of chemical products
9. Chemical products that are subject to the procedure of customs transit
7Additional exceptions
 Preparative forms of pesticides and associated processes of their
manufacture, storage, transportation, sale and disposal(see item 4 of Decision No. 19)

 Certain types of chemical products subject to other (“vertical”) technicalregulations of the Union with respect to conformity assessment
note: hazard classification, SDS and labelling are still required)(see Article 1, item 3 of TR)

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Examples of vertical technical regulations
Technical
regulations

requirements for:Conformity
assessment form

hazardclassification

warninglabelling

SDS

TR of Customs
Union 013/2011–––

declaring

TR CU 028/2012+––

certification

TR CU 030/2012–++

declaring

TR EAEU
036/2016–––declaring

TR EAEU
039/2016+++registration

TR CU 013/2011 «On requirements for the motor gasoline and aviation motor gasoline, diesel and marinefuels, jet engine fuel and black oil fuel»TR CU 028/2012 «On the safety of explosives on their basis»
TR CU 030/2012 «On requirements for lubricants, oils and special fluids»
TR EAEU 036/2016 «Requirements for liquefied petroleum gases for use as fuel»
TR EAEU 039/2016 «On the requirements for mineral fertilizers»

91. Basic information – 2. How to be ready – 3. Latest Updates

10Step by step procedure

Chemicalproductidentification

Do you have anewsubstance? notification

Hazardclassification
SDS

Conformity
assessment

Labellingor11

Rules for identification
The identification of chemical products is carried out by the manufacturers (personsauthorized by foreign manufacturers – “Only representative”) or the importer
It includes assignment of chemical products to chemicals and mixtures[in terms of TR EAEU 041/2017]
For Substance

For Mixture

Main substance
Hazardous substances in additives and impurities
in concentration > 0,1% (mass)

Components > 10% (mass)
Hazard components in concentration > 0,1%(mass)

New substances in concentration > 0,1%
For each of the identified substances:
IUPAC nameCAS number
Status of circulation on the territory of the Union (is it prohibited or restricted)

12Notification of new substances
If a substance (individual or as a part of the mixture) is not included in the register ofsubstances and mixtures of the Union, such substance is considered to be new to theEAEU market and shall undergo the notification procedure
Data for submission to a competent authority include:Chemical safety report
Identification data
Physical-chemical properties
Data on toxicity and eco-toxicity
Intended uses
Method of disposal andtransportation as well as
measures for risk prevention andelimination

…
Copies of data (protocols) of studies on thedetermination of bioaccumulation,
carcinogenicity, mutagenicity and toxicity,
conducted in laboratories (centers)
recognized as consistent with theprinciples of GLP(see item 48 of TR EAEU 041/2017)

Result is the entry of information about the substance in the registry13Register of substances and mixtures of EAEU
- an information resource containing data on the chemical substances and mixturesproperties, including information on the prohibition, restriction, or permission to use
it in the Union customs territory

Inventory

Database

According to Decision No.19 of the EEC Council of 3 March 2017 the national partsof the Union register shall be formed by 1 March 2021

Register of substancesand mixtures of Union

National parts of the Register
The procedure for the formation and maintenance of the register as a whole is to beestablished by the Eurasian Economic Commission within the second-tier document.

14Hazard classification-SDS-Labelling
Carried out by the manufacturers (persons authorized by foreign manufacturers – “Onlyrepresentative”) or the importer before the release of chemical products in circulation in
the customs territory of the Union.
The technical regulations contain general provisions. The criteria are set in the standards
Hazard classification
GOST 32419-2013 Substanceclassification. General requirements(under revision)

SDS

Labelling

GOST 30333-2007 Safety DataSheet(under revision)

GOST 31340-2013 Labelingof chemical products(under revision)

GOST 32424-2013 Environmental
hazards classification for substances
GOST 32423-2013 Classification ofmixtures for health hazards
GOST 32425-2013 Environmental
hazards classification for mixtures15

Conformity assessment
in form of state registration
PERMITTING stateregistration

NOTIFYING state registration

When does itapply?

– Chemical product, on which information
is included in the register, and in its
composition:a) there are no prohibited substancesb) concentration of hazardous
substances restricted for use does notexceed the specified limits

Limit values of restricted substances(see Annex 4 of TR)
New chemical product – a chemical productwhich is a new substance or containsa new substance(s)– New chemical products– Chemical products that
contain restricted
substances inconcentrations exceeding
the specified limits

Hazards typeConcentration(by weight)

Carcinogen (class 1 and 2)0,1%

Mutagens (class 1)

0,1%

Mutagens (class 2)

1%

Reproductive toxicant (class 1 and 2)

0,1%

Chronic aquatic toxicity (class 1)

1%
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State registrationWhat
documents are
required tosubmit?

How long are
the documentsreviewed?

Result in caseof compliance

Validity

NOTIFYING state registration

PERMITTING state registration

 Application
 Safety Data Sheet (GOST 30333)
 Protocols (if any) of studies and(or) documents containing datafrom official information sources Application
 Safety Data Sheet (GOST 30333)
 Protocols of studies and (or)documents containing data fromofficial information sources Information within notification
procedure (if applicable)

10 working days

45 working days

Assignment of an individual registration number to the product
Generation of an entry in the register of chemical products
Issuance of a certificate on
notifying state registration ornote in electronic form
Unlimited

Issuance of a permission to use5 years(automatic re-registration in theabsence of comments)

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Who can submit?
According to clause 51 of TR EAEU 041/2017:“…. applicants can be legal entities registered in accordance with the legislation of a EAEU member
state on its territory or individuals as individual entrepreneurs, who are manufacturers (authorizedby the manufacturer), importers of these products"
A person authorized by a manufacturer is a legal entity or an individual registered in accordance withthe legislation of a member state of the Union on its territory as an individual entrepreneur who, on
the basis of an agreement with a manufacturer, including a foreign manufacturer, act on behalf of thismanufacturer in the course of conformity assessment and release into circulation of products on theterritory of the Union, and are also responsible for non-compliance of products with therequirements of the technical regulations of the Union [see Appendix No. 9 to the Treaty on theEurasian Economic Union].
Thus, there must be an agreement between the foreign manufacturer and an authorized person, whichindicates:
1. The right of an authorized person to act on behalf of the manufacturer when assessing(confirming) compliance and releasing (placing) products on the territory of the Union
2. The responsibility for non-compliance of products with the requirements of the technicalregulations of the Customs Union.
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1. Basic information – 2. How to be ready – 3. Latest Updates

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Second-tier documents to TR EAEU 041/2017
 The procedure of formation and maintenance of the register of substances andmixtures of the Union
 The procedure of new substances notification
These documents detail the technical regulation provisions.
Without them, the implementation of technical regulation in practice is impossible.
01/12/2018

01/03/2021

Two second-tier documents shall beelaborated, approved and implemented

National partsof the Union Registershall be formed

30 months

From the date of fist milestone(Proposed Option1)

2 June 2021
Entry into force
Provided internal deadline(of 2018) is met*

30 November 2022

(Proposed Option 2)- The earliest possible date

Other options under discussion*Decision of 3 March 2017 No.19 of the Council of the Eurasian Economic Commission

20Content of second-tier docs
The procedure of formation and maintenance of the Union Registry (with 8 Annexes)→ Registry structure and stages of its formation→ List of restricted substances (Annex 7) – agreement is not reached→ The ability to use information from national and international databases →→ List of official information sources on chemicals (Annex 3)→ The ability to use alternative methods (read-across, grouping, QSAR) insteadof testing→ Single window mode for submission of a set of documents→ CBI protection→ Joint data submission for the permitting state registration
The procedure for the notification of new substances (with 2 Annexes)→ The order of notification (required documents and timeframe)→ Recommendations for completing a chemical safety report (Annex 2)→ The possibility of a phased submission of information regarding the new substance(part 1 of CSR + strategy for further testing)→ The ability to use information from databases (if available) and alternative methods
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Proposed steps for Register formation
From …
Until 01/03/2021*

Inventory ofsubstances in Union
member states anddata transfer to theCommission
Limited set of data
Data from industry

Creation of thecommon list by theCommission andpublication of theUnion inventory ofsubstances
Merging duplicateentries

Formation ofnational parts of
the register ofsubstances.
Transfer of “open”
data to theCommission forpublication
Data obtained bycurrent conformity
assessment, fromindustry and fromsources according
to Annex 3*According to Decision No.19 of the EEC Council of 3 March 2017

Formation ofnational parts of
the register ofmixtures. Transferof “open” data tothe Commission
for publication

During the stateregistration ofchemical products,
which areconsideredmixtures

22Inventory formation in Russia
Lasts from May 2019 till October 2020 (data submission November 2019- August 2020)
List of chemicals – the basic for the register formation
Results: https://gisp.gov.ru/cheminv/pub/app/search/

Over80 000
substances
23Deferred norm
before June 2, 2023 companies have the right to submit information
on a chemical substance for inclusion in the Register without anotification procedure, but with attaching of the documents that
confirm the circulation of a chemical substance on the Union market
before the effective date TR EAEU 041/2017.
Confirming documents may include:
a supply agreement (an act of purchase and sale),consignment note,
information on the presence of a chemical substance in thenational list of chemicals of a Member state, etc.

Please note:
After the entry into force of the TR EAEU 041/2017 and the termination of the deferred norm,
you must notify all chemical substances that are not in the Register before it being released tothe Union market (even as part of the mixture)!
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Deferred norm for State registration
If an imported chemical product is a SUBSTANCE
Tonnage for one legal entity (LE) per year
> 1000 t/y
100-1000 t/y
1-100 t/y
< 1 t/ySTART of state registration (DRAFT Decision)as soon as TR EAEU 041/2017 comes into force(30 November 2022 - at the earliest)
30 November 2024
30 November 2026
Additional 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
100-1000 t/y
10-100 t/y

START of state registration (DRAFT Decision)
30 November 2027
30 November 2029
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 30333 and labelling under 31340 are required from the date TR EAEU
041/2017 comes into force

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Coordinating Informational Centerof CIS Member States on approximation of regulatory practices
00

Thank you for your attention!
Questions?
n.druzhinina@ciscenter.org+7 (495) 128-95-45
www.ciscenter.org

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