FAQ:Declaration of conformity to the TR EAEU 037/2016

The new Technical Regulation of the EAEU 037/2016 "On Restriction of Use of Hazardous Substances in Electrical and Radio Electronic Products" (hereafter – the Regulation) entered into force on March 1, 2018. Starting from March 1, 2020 (the end of the Regulation’s transition period), release into circulation (including production, import, sale) of products in the scope of the Regulation is prohibited without confirmation of compliance with its requirements.

Technical Regulation (TR) EAEU 037/2016

What are the requirements of TR EAEU 037/2016? What does it regulate?

This Regulation restricts the use of hazardous substances in electronic goods. There are six such substances in the Regulation:

All of these substances are highly toxic and can accumulate in the environment if electronic products are disposed incorrectly. TR EAEU 037/2016 limits the maximum concentration of these substances in individual (homogeneous) components of goods at a level of no more than 0.1% by weight (for cadmium-no more than 0.01%).

TR EAEU 037/2016 was developed on the basis of similar legislation of the European Union, namely, a series of EU Directives under the general name RoHS (Restriction of Hazardous Substances).

What products are covered by TR EAEU 037/2016?

The list of products that are subject to TR EAEU 037/2016 is specified in Appendix No. 1 to the regulation.

In particular, the Regulation applies to household equipment (for example, washing machines, refrigerators, telephones), personal computers (PCs) and equipment that is connected to PCs (scanners, printers), light sources (light bulbs, lamps), cables, etc.

At the same time, paragraph 3 of the Regulation specifies the groups of products that the regulation does not apply to. TR EAEU 037/2016 does not apply to: medical products, measuring instruments, electric toys, batteries and accumulators, high-voltage equipment, etc.

Also, the Decision of the EEC Board No. 167 of 16.10.2018 established a list of goods (with the EAEU HS codes) which require the confirmation of compliance with the requirements of EAEU TR 037/2016 for customs clearance. Customs authorities mostly rely on this list.

What components of the products may contain dangerous substances?

For example, these parts may contain lead and cadmium:

paints and pigments,
PVC (vinyl) cables (e.g. power cords, USB cable), solders,
printed circuit boards,
glass in television and photographic products (for example, CRT television screens and camera lenses),
metal parts,
lamps and light bulbs,
integrated circuits or microchips,
nickel-cadmium (NiCd) batteries.

Mercury is often used in daylight lamps and automotive lightning. Hexavalent chromium is added to alloys to increase hardness and prevent corrosion, for electroplating (chromium plating). Polybrominated biphenyls and diphenyl ethers / oxides are mainly used as flame retardants (for prevention or slowing the development of ignition).

What is the RoHS Directive?

On July 1, 2006, Directive 2002/95/EC^[1], the first of the RoHS directives, entered into force in the European Union. Adoption of this directive was one of the key steps in the European program to counter the harmful effects of electronic waste on the environment. The Directive was adopted with the aim of limiting the content of certain hazardous and harmful substances in electrical and electronic equipment.

On July 1, 2011, Directive 2011/65 / EU^[2] (RoHS 2) came into force and replaced the 2002/95 / EC (RoHS 1) directive.

RoHS 2 sets limits on the use of the same hazardous substances as RoHS 1 (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers) in electrical and electronic equipment. The only difference is that the RoHS Directive 2 has a more extended scope of the products covered and introduces new obligations and requirements for manufacturers of electrical equipment. The preparation of the EU declaration of compliance with the requirements of the directive became the main obligation. Only in the presence of the specified compliance, the manufacturer has the right to apply the CE marking on its products.

In 2015, the 2015/863 amendment to the RoHS 2 directive was adopted. The amendment expands the list of hazardous substances that are subject to restriction to 10. The following 4 substances were added:

Bis (2-ethylhexyl) phthalate
Butyl benzyl phthalate
Dibutyl Phthalate (DBP)
Diisobutyl Phthalate (DIBP)

Application of the requirements of the RoHS directive 2015/863 is mandatory for products released into circulation after July 22, 2019.

Which countries is RoHS valid in?

EU directives apply to the territory of the European Union. Manufacturers of electronic goods willing to sell their products in the EU market are required to comply with the requirements of the RoHS directives.

Some other states have similar legislation (e.g., some US states: California, New Jersey, Illinois, Indiana, etc., China, Japan, Korea)^[3].

What are the main similarities and differences between TR EAEU 037/2016 and RoHS?

TR EAEU 037/2016 and RoHS Directive 2011/65/EU have similar scope of application. Both documents cover electronic devices and household appliances, IT (computer) and telecommunications equipment, lighting devices, power tools, etc.

Both regulations set the same restrictions on the use of six hazardous substances (Lead, Mercury, Cadmium, Hexavalent Chromium, Polybrominated Biphenyls and Polybrominated Diphenyl ethers) at the level of no more than 0.1% of the weight (for cadmium — no more than 0.01%).

Compliance with the requirements of TR EAEU 037/2016 and RoHS Directive is confirmed by issuing a Declaration of Conformity (TR EAEU or EU). In both cases, after confirming the conformity of the product, it is necessary to apply the compliance mark ("EAC" or "CE").

However, there are some significant differences:

Application areas slightly vary

For example, RoHS Directive 2011/65 / EU applies to electric toys and medical equipment that are excluded from the scope of the EAEU TR 037/2016 (separate technical regulations have been adopted or are being developed for these types of goods). In turn, TR EAEU 037/2016 has security and fire alarm systems and detectors that are not included in the Directive. It should also be mentioned that the names of the groups of goods included in these documents are somewhat different, which can make additional difficulties, for example, when using foreign protocols for declaring compliance with TR EAEU 037/2016.

With the adoption of amendment 2015/863 in 2015, the Directive also restricts the concentration of four more hazardous substances (bis (2-ethylhexyl) phthalate, butyl benzyl phthalate, dibutyl phthalate (DBP), diisobutyl phthalate (DIBP). TR EAEU 037/2016 currently does not set restrictions on these substances, and there is no information on plans to develop the Regulation in this direction.

The procedure for confirming compliance in the EAEU implies the official registration of the declaration of conformity. The Directive does not require the registration of a declaration, but it is important to keep records of products of inappropriate quality.

How to confirm the compliance of products with the requirements of TR EAEU 037/2016?

The applicant must prove that none of the homogeneous materials presented in the product contain dangerous concentrations of hazardous substances. This can be confirmed by conducting product tests.

The decision of the EEC Board No. 108 establishes standards that define test methods and rules for sampling. These standards specify how tests are conducted, under what conditions, what measuring equipment is required, and what happens to the samples during testing. Basically, most test methods provide for destructive testing (samples cannot be restored after testing). Test results are usually recorded in test reports. After comparing the measured numbers and the established norms (limits), the ultimate conclusion is made whether the product complies with the Regulation requirements.

The use of test reports and other evidentiary materials from foreign laboratories is not prohibited, but only if these reports can be used to make conclusion about compliance (or non-compliance) of products with the established requirements.

What documents confirm compliance with TR EAEU 037/2016 requirements?

According to clause 18 of the regulation, a Declaration of Conformity is required, issued according to one of the following schemes:

for series-produced products — schemes 1d, 3d and 6d;
for a batch of products — schemes 2d and 4d.

At the applicant's choice, the declaration can be replaced the certificate (though the procedure of confirmation of compliance will be much more complicated in the latter case).

Tests

I want to conduct tests in the EAEU. How and where can I do that?

For declaration it is possible to do the tests in listed organizations:

in the manufacturer's testing laboratory (production laboratory);
in a laboratory accredited in the territory of the EAEU (such a laboratory will be listed in the Register of accredited conformity assessment bodies);
in other laboratory (not necessarily accredited, including foreign laboratory).

First of all, the applicant must conclude a contract with the Testing Laboratory (hereinafter referred to as the TL), agree with the TL on the required number of samples for testing, as well as the specified test procedures.

Samples produced abroad (outside the territory of the EAEU) must be imported into the EAEU country, where the tests will be carried out, and delivered to the laboratory. Usually, this process is organized by the applicant on their own. Samples must be imported in compliance with the requirements for the import of samples with the registration of the Customs Declaration for the goods (CD).

After passing the tests, the applicant will have the testing protocols on hands.

The duration of the tests depends on the laboratory.

For certification the applicant must first form the necessary package of documents, submit them to the Certification Body (hereinafter — CB), accredited for TR EAEU 037/2016, receive a decision from the CB on the possibility or impossibility of certification. If the decision is positive, then an agreement is concluded between the applicant and the CB, and only then it is possible to proceed to product testing.

The applicant agrees with the CB in advance on the number of test samples and the test procedures. The applicant imports samples with the registration of CD. It should be noted that in this case, all the details of testing are negotiated with the CB, not with the TL. After passing the tests, the TL sends the protocols to the CB for further registration of the Certificate of Conformity.

The tests usually take 14-20 working days.

Compliance tests for certification can only be carried out in an accredited TL.

It is important to remember that certain steps in the certification and declaration of products depend on the chosen certification/declaration scheme.

Which test methods are used?

The interstate standards of the EAEU provide for the following methods for determining the content and concentration of hazardous substances in electrical engineering products:

XRF (X-ray fluorescence analysis)
IC (Ion chromatography)
CIC (Ion chromatography of combustion products)
AAS (Atomic absorption spectrometry)
AFS (Atomic fluorescence spectrometry)
GC-MS (Gas chromatography-mass spectrometry)
HPLC-UV (High-performance liquid chromatography-ultraviolet)
ICP-OES (Inductively coupled plasma optical emission spectrometry)
ICP-MS (Inductively coupled plasma mass spectrometry)
IAMS (Ion-attachment mass spectrometry)

Review of screening and verification procedures. Types of substance^[4]

Procedure	Type of substance	Polymers	Metals	Electronics (PWBs / Components)
Analytical measurements	Organic compounds (e.g. PBDEs)	GC-MS IAMS HPLC-UV	Not defined	GC-MS IAMS HPLC-UV
	Elementary bromine	XRF IC	Not defined	XRF IC
	Ionic forms (for example, Cr + VI)	Colorimetry/UV-VIS	Colorimetry/UV-VIS	Colorimetry
	Elementary analysis (of metals) (e.g. Pb, Cd)	XRF, AAS, CV-AAS, CV-AFS, ICP-OES and ICP-MS

Before applying these procedures, as a rule, the preparation of the studied components is carried out in various ways:

Procedure	Sample preparation	Polymers	Metals	Electronics (PWBs / Components)
Sample preparation	Non-destructive preparation	Without preparation	Without preparation	Without preparation
	Mechanical sample preparation	Crushing/grinding	Crushing/grinding	Crushing/grinding
	Chemical preparation of the sample	Water dilution/alkaline treatment; Acid decomposition; Dry salting; Extraction with organic solvents; Oxidation/Extraction; Thermal amalgamation with gold.	Acid decomposition	Water dilution/alkaline treatment; Acid decomposition; Extraction with organic solvents; Oxidation/extraction.

Of the listed methods, only XRF is non-destructive (using modern equipment).

What are homogeneous components (materials)?

Homogeneous materials are those with a constant composition in its entire volume, consisting of a single substance or a combination of substances and (or) materials that cannot be separated by mechanical means (by disassembling, cutting, grinding, grinding or other mechanical action).

TR EAEU 037/2016 restricts the concentration of hazardous substances in homogeneous components of the product. During testing, the product must first be separated into such components, for example, conductors must be separated from insulation, microcircuits and electronic parts must be separated from metal terminals, printed circuit boards must be separated from solder, the product body must be cleaned of paint, etc.

Even with non-destructive screening methods, the product is usually irreversibly destroyed during separation into homogeneous components.

How do I import the samples?

Goods imported into the territory of the Russian Federation for the purpose of testing (hereinafter referred to as test samples) are subject to customs declaration in accordance with Article 104 of the Customs Code of the EAEU. There is no need to provide documents confirming compliance with Technical Regulations (declarations or certificates) for samples, but other permits may be required (for example, for electronic goods, documents authorizing the import of cryptographic devices and radio-electronic devices are most often required).

Also, before sending samples, one must prepare documents listed below:

Copy of the contract with an accredited certification body (CB) or testing laboratory (TL);
A letter from the CB or TL, confirming the quantity (weight and volume (pcs.)) of imported product samples required for these purposes.c

If the applicant registers the Declaration of Conformity on their own through the Federal Service for Accreditation (Rosaccreditation), the contract with the Certification Body is not required.

When the test samples arrive at the customs office, they undergo the customs clearance procedure with registration of customs declaration (hereinafter referred to as CD). In this case, the CD is issued as follows:

in field 31, after the description of the product, the words "samples for the purpose of confirming compliance" should be written.
in field 37, the code "061"is written. This code, in accordance with the Classifier of the characteristics of the movement of Goods, defines the import of goods as samples for research and testing.
in field 44 under the document type code "01999" the details of the documents are indicated, namely the details of the contract and the letter from the CB / TL.

A copy of the CD (or CD number) for the samples is included into the package of documents for registration of the certificate/declaration of conformity, as a proof that the samples were actually imported for the testing.

Previously released products cannot be used as test samples.

Are the samples returned after testing?

If the use of a non-destructive screening method is sufficient, and the sample is not irreversibly destroyed during preparation (separation into homogeneous components), it is possible that the sample will be returned to the applicant. Otherwise, the sample is disposed of, and the applicant is provided with an act of disposal.

One or another option is selected by the testing laboratory based on the results of the analysis of the provided sample.

How long do the tests last?

The duration of the tests depends on the conformity assessment scheme and the test procedure. On average, the tests last from 7 to 20 working days.

At the same time, the durations of the tests in accredited laboratories are close to 14-20 working days.

Testing may take significantly longer if the laboratory is highly loaded.

Declaration of conformity with TR EAEU 037/2016

Can I issue a certificate instead of the declaration? What are the advantages and disadvantages?

Clause 25 of TR EAEU 037/2016 allows, at the request of the applicant, to issue a Certificate of Conformity instead of the declaration.

The certification procedure is more complex than the declaration procedure. In particular, during certification, tests are carried out only in accredited laboratories, and only the body that has the accreditation of TR EAEU 037/2016 and the corresponding GOST standards are entitled to issue a certificate. In addition, certification implies a mandatory visit to the production site and yearly Surveillance.

My product is subject to several regulations. Is it possible to issue only one document?

If the form of confirmation of conformity is compatible for all the necessary technical regulations (for example, all regulations allow the registration of a Declaration of Conformity for your product), and the certification body (and/or testing laboratory) has all the regulations and the HS code of your product in the field of accreditation, you can issue a single document of compliance.

This issue should be clarified with the certification body (laboratory) in each specific case, since there may also be difficulties of a purely technical nature (for example, the laboratory may currently lack of the equipment necessary for testing according to one of the regulations).

What is the period for processing documents for TR EAEU 037?

On average, the period for receiving a document is 14-20 working days, which includes:

10-14 days of testing of samples and registration of the test report(s);
1-2 days are spent on registration of the Declaration/Certificate of Conformity.

It is recommended to plan the preparation of documents in advance.

How long is the Declaration of Conformity to the EAEU TR 037/2016 valid?

According to the Regulation, the validity period of the Declaration of Conformity for series-produced electrical and radio electronics products is no more than 5 years.

For batches of electrical and radio electronics products, the validity period of the declaration of conformity is not set.

Is it possible to make changes in Declaration of Conformity of TR EAEU 037/2016?

According to the Decision of the EEC No. 41 of 20.03.2018, amendments to the registered Declaration of Conformity are not allowed. If necessary, the applicant registers a new Declaration of Conformity.

You can also cancel an existing declaration.

How to check the status of the Declaration of Conformity to TR EAEU 037/2016?

The authenticity and status of Declarations of Conformity can be verified in the Common Register on the Eurasian Economic Commission website or in the national registers of the EAEU member countries. In the Russian Federation the register of registered declaration of conformity is published on the website of the Federal Accreditation Service (Rosaccreditation).

On the EEC website, click on the "Search Details" link above the main table and enter the number of the Declaration of Conformity in the "Document Registration Number" field. On the Rosaccreditation website, the field for the declaration number is located on the left in the "Filters" section".

National registers usually display much more information about the declaration, including (for the Rosaccreditation register) information about the manufacturer and its branch offices, expanded information about products, information about tests and standards, information about status changes.

Miscellaneous

Is there Surveillance procedure?

Surveillance or Inspection control (IC) is carried out only for issued Certificates of Conformity for series-produced products. It is not required to carry out an IС in relation to declarations of conformity.