You cannot place a product on a retail shelf, a marketplace or into a tender without conformity documents - the product will be pulled from sale and the seller fined. Yet some products need a certificate, others a declaration, others a state registration certificate, and for some an exemption letter is enough. Let's break down how the conformity assessment system works and how to determine exactly what your product requires.
Certificate and Declaration: What's the Difference
Both forms confirm that a product meets mandatory requirements. The difference lies in who bears responsibility and how the procedure is organized. With certification, the assessment is carried out by an independent accredited body: it selects the samples, analyses the evidence and issues the document on its own letterhead. With self-declaration, the applicant - the manufacturer or importer - takes on responsibility for conformity, and registers the declaration in the accreditation body's public registry.
A common misconception is that a declaration is 'weaker' or 'less serious'. Legally it is an equivalent form of conformity assessment: a product with a registered declaration circulates on the market just as lawfully and carries the conformity mark just the same. Lawmakers simply chose different forms for different product groups depending on the potential risk.
| Parameter | Certificate of conformity | Declaration of conformity |
|---|---|---|
| Who is responsible for the result | Certification body (third party) | The applicant - manufacturer or importer |
| Who issues the document | The body, on its own letterhead | The applicant, with registration in the registry |
| Sample selection | Usually by the body | By the applicant |
| Where to verify | Accreditation body's public registry | Accreditation body's public registry |
| Legal force | Confirms conformity | Confirms conformity |
| Conformity marking | Yes | Yes |
You do not choose the form of assessment yourself. For each product group it is set by regulation - either by a technical regulation or by a national product list. Your task is to correctly determine which group your product belongs to.
What Are Technical Regulations
A technical regulation is a document that sets out mandatory product safety requirements. Technical regulations - and the international directives and standards behind them - establish rules that apply across an entire market or trade bloc. If a product falls under at least one such regulation, conformity assessment is mandatory.
There are dozens of such regulations, each covering its own area. Food products, for instance, are governed by food safety regulations (HACCP, ISO 22000); low-voltage equipment by electrical safety directives; textiles and apparel by light-industry standards; and goods for children and adolescents by toy and child-product safety standards. The same product may fall under several regulations at once - in which case conformity must be confirmed under each of them.
First you determine which regulations apply to the product, and only then which form (certificate or declaration) and which scheme within it is used. The regulation itself, in its annexes, specifies the form of assessment for each subgroup.
National Standards, Product Registration and Exemption Letters
Beyond the main technical regulations there are several other documents that are often confused.
- National-standard certificates and declarations. A national system. Products not covered by bloc-wide regulations are assessed against a national product list set by domestic regulation. Separately, there is voluntary certification against national or ISO standards - obtained on one's own initiative to demonstrate quality to buyers and tenders.
- State registration certificate. Issued by the health and sanitary authority for products under sanitary-epidemiological oversight: baby and specialized food, dietary supplements, certain cosmetics and household chemicals, disinfectants. This is the strictest status.
- Exemption letter. An informational document stating that a product is not subject to mandatory conformity assessment. It is not officially a form of assessment, but customs and marketplaces request it to confirm that documents are absent not because they were 'forgotten', but because the product genuinely falls outside the mandatory lists.
Conformity Marking: When and How
The conformity mark (such as the CE mark) confirms that a product has passed all the necessary procedures for assessing conformity with the applicable technical regulations. It may only be applied once a certificate has been issued or a declaration registered for the product. The mark is placed on the item, its packaging or the accompanying documentation.
Applying the conformity mark without a valid conformity document is a violation. Regulators may withdraw the batch from circulation and impose administrative penalties. Conformity marking is not about packaging design - it is about having documented, confirmed conformity.
When Testing Is Required
Both certificates and many declarations rest on an evidence base - test reports. Product samples are checked in an accredited laboratory against the safety parameters set by the regulation: electrical safety, composition, hygiene characteristics, durability and so on. Without a test report a body will not issue a certificate, and a registry will not accept a declaration based solely on in-house evidence.
The scope of testing depends on the assessment scheme. Serial production carries more requirements than a single batch, and usually adds an audit of the production process. For some declarations an evidence base compiled by the applicant itself is permitted, but even then correct test reports are required.
How a Product Ends Up on Mandatory Certification Lists
The decision process comes down to a few checks that are convenient to work through step by step.
The product line is identified by HS (Harmonized System) and product classification codes. The correct code drives all the logic that follows.
Determine which technical regulations the product falls under. There may be several at once.
If no regulation applies, check the national product list - it specifies the form and the products covered at the national level.
Food, children's, cosmetic and sanitary-sensitive products may require a registration certificate from the health authority.
By the end you know: certificate, declaration, state registration or exemption letter - and which scheme to use.
What Marketplaces and Tenders Require
Today conformity documents are most often demanded not by customs, but by two sales channels.
- Marketplaces. Amazon, eBay and other major marketplaces request a certificate, declaration or exemption letter when a listing is created, depending on the category. Without a document the listing can be blocked and the product removed from the storefront. Platforms spot-check documents against public registries.
- Tenders and public procurement. In public and corporate procurement, conformity assessment is often part of the requirements for bidders and of the technical specification. The absence of a valid document is grounds to reject the bid.
Keep in mind separately that mandatory product serialization is not certification. It is a traceability system for specific product groups, and it does not remove the need for a certificate or declaration. A conformity document and a serialization code are different obligations that often apply at the same time.
A conformity document is not paperwork for a folder - it is a pass to the market: without it there is no shelf, no marketplace, no tender and no lawful import.
Frequently Asked Questions
How does a certificate of conformity differ from a declaration?
With certification, an independent accredited body is responsible for the assessment and issues the document on its own letterhead. With self-declaration, the applicant confirms conformity itself and registers the declaration in the accreditation body's registry. Legally these are equivalent forms, and the form for a specific product is set by the regulation or list, not by the applicant's preference.
What is an exemption letter and does it replace a certificate?
An exemption letter is an informational document stating that a product is not subject to mandatory conformity assessment. It does not replace a certificate or declaration; it is used when they are not needed: marketplaces and customs request it to confirm there are no mandatory requirements for the product.
Is product testing required for a declaration?
Most often, yes. A declaration rests on an evidence base, and for most groups test reports from an accredited laboratory are required. Some schemes allow an evidence base compiled by the applicant itself, but even then correctly prepared test reports for the regulation's parameters are needed.
Which document is required to sell on a marketplace?
It depends on the product category: the marketplace will request a certificate, declaration or exemption letter. Platforms check documents against public registries and may block a listing without confirmation. The form should be determined from the applicable technical regulations and the national product list.
What does the conformity mark on packaging mean?
The conformity mark confirms that a product has passed assessment against the requirements of the applicable technical regulations and that a certificate has been issued or a declaration registered for it. The mark may not be applied without a valid document - doing so is a violation with the risk of batch seizure and fines.
We'll Help Determine What Your Product Needs
G-Invest breaks down your product range by codes and regulations, determines the form of assessment - certificate, declaration, state registration or exemption letter - and guides the paperwork to meet marketplace and tender requirements. Without unnecessary procedures or overpaying for documents you don't need.