In March of this year, the responsibility of business in the field of production and sale of non-food products increased significantly. Therefore, interest in inspections in this area has increased.
Therefore, we will help you find out which body and when can check your products. This will allow you to prepare for such a test.
Let's start from the beginning. There is one basic law for all non-food safety inspections - the Law of Ukraine “On State Market Supervision and Control of Non-Food Products”. We will continue to call it simply - the Law.
Also at the beginning we will make a small remark. Imported non-food products can actually be controlled twice. It is first inspected by customs authorities during customs clearance, and then by market surveillance authorities. We will not talk about inspections during customs control here, but will move to market surveillance.
It should be noted at once that this article is quite voluminous, because we have described step by step all the stages of the inspection and its consequences. However, each situation is individual. If you could not find the answer to your question, then write it in the comments or contact us for help
There are actually quite a few market surveillance authorities. The main body is the State Food and Consumer Service. In particular, it is it that inspects those products for which the technical regulations do not set special requirements for ensuring their safety and for which other bodies are not directly designated to carry out such supervision.
In addition to the State Food and Consumer Services, certain types of products are supervised by: the Maritime Administration, Ukrtransbezpeka, the State Emergency Service, the State Labor Service, the State Medical Service, and the State Coinspection. The scope of supervision of each of these bodies is determined by the resolution of the Cabinet of Ministers of Ukraine №1069 of 28.12.2016 "On approval of the list of types of products in respect of which state market surveillance authorities carry out state market surveillance." Market surveillance authorities cannot duplicate each other.
What is being checked?
The subject of market surveillance is compliance with the general requirements for the safety of non-food products.
The legislation contains a rather complex and voluminous definition of safe non-food products (Article 1 of the Law of Ukraine "On General Safety of Non-Food Products").
It is safe any product which, under normal or reasonably foreseeable conditions of use (including service life and the need for commissioning of installation and maintenance requirements) does not present any risk or presents only minimal risks due to the use of such products, which are considered acceptable and do not pose a threat to the public interest, taking into account:
- product characteristics, including its composition, packaging, installation and maintenance requirements;
- the impact of products on other products, if it will be used with it;
- warnings contained on the product label, instructions for its use and disposal, as well as other product information;
- warnings about the consumption or use of products by certain categories of the population (children, pregnant women, the elderly, etc.).
Any product that does not meet the above definition is considered dangerous. This is also explicitly stated in Article 1 of the Law of Ukraine "On General Safety of Non-Food Products".
Given that the scope of supervision of each of the regulatory authorities is usually limited to verifying compliance with the requirements of a technical regulation, it is the technical regulations and are the main guidelines for compliance with the requirements for the safety of non-food products.
In addition to technical regulations, the safety of non-food products is determined by some state standards. The vast majority of standards are applied on a voluntary basis, unless their application is required by law. Article 23 of the Law of Ukraine "On Standardization" requires the standardization body - SE "UKRNDNC" to publish a list of such mandatory standards on its website.
How to check?
Market surveillance is carried out by conducting scheduled and unscheduled inspections of product characteristics.
The inspection can be off-site, on-site and mixed. The type of inspection is chosen by the supervisory body at its own discretion.
Non-departure is carried out at the location of the supervisory body, and departure can be carried out both in trade and warehouse premises of business entities, and in places of use of products during its installation and / or commissioning, as well as at the fair, exhibition, demonstration etc.
The fundamental difference between on-site and off-site inspections is the scope of the inspection. During the off-site check only documents and information about the products are checked, but during the on-site inspection, selection and examination (testing) of product samples can be additionally carried out.
The law also limits the duration of the on-site inspection to two days for the distributor and three days for the manufacturer. The time of the examination is not taken into account until these terms. Instead, there are no restrictions on the deadlines for on-site inspections in the Law.
Where to look for inspection plans?
Scheduled inspections can be carried out only at distributors of products, and not at its manufacturers.
Inspection plans in the field of market surveillance are called sectoral. They are approved annually until the first of December year preceding the planned and no later than three working days from the date of their approval are published on the official website of the relevant supervisory authority.
What are the features of unscheduled inspections?
The scope and nature of an unscheduled inspection depends on who conducts it, the manufacturer or the distributor.
The basis for inspection by the distributor of products may be:
1. at the request of consumers (users) of relevant products, as well as executive authorities, executive bodies of local councils, law enforcement agencies, public consumer organizations, which contain information about the distribution of products that harmed the public interest, and no information on which the manufacturer such products can be identified, but contain information by which the distributor from whom such products were purchased can be identified;
2. if during the verification of the characteristics of the products of the manufacturer of the relevant products the manufacturer proves that:
- he did not put into circulation dangerous products;
- the product is dangerous as a result of the actions or inaction of the distributor of such products.
Unscheduled inspection is carried out in two stages:
At the initial stage it is checked:
- the presence on the products of a mark of conformity to technical regulations and compliance with the rules of its application and application;
- the presence of accompanying documentation, which must be attached to the relevant products, labels, markings, other marks established by technical regulations;
- availability of a declaration of conformity.
At the next stage, the market surveillance authority may inspect samples of the relevant products and identify the manufacturer of the products, as well as take samples and conduct an examination of the products if it has reason to believe that the products are dangerous.
If the distributor does not document who is the manufacturer, then for the purposes of the Law he is considered the manufacturer and will bear increased responsibility.
Manufacturers conduct unscheduled inspections:
1. if, based on the results of the distributor's inspection, there are grounds to believe that the product is dangerous as a result of the actions or inaction of its manufacturer;
2. at the request of consumers of relevant products, as well as executive authorities, executive bodies of local councils, law enforcement agencies, public consumer organizations, which contain information on the introduction of products that have harmed the public interest, as well as information on which the manufacturer products can be identified;
3. in the case of receiving through the system of operative mutual notification about products that pose a serious risk, or in another way from the authorized bodies of other states information about products that pose a serious risk, if its manufacturer is identified and is a resident of Ukraine.
During such an inspection, the market surveillance authority may take the same measures as during the inspection of distributors, as well as in addition:
- check the full composition of the technical documentation for the relevant products provided by the technical regulations;
- check the documents on the quality system or quality management system, if their provision is provided by the technical regulations for the relevant type of product.
What documents are subject to verification?
The following documents and information are checked during the on-site inspection:
- declaration of conformity;
- accompanying documentation attached to the relevant products (including instructions for use of products);
- general description of the product and scheme (drawing) of the product design, as well as the full composition of the technical documentation for the relevant products, provided by the technical regulations;
- documents on the quality system or quality management system;
- conclusions of examinations and test reports of samples of relevant products taken (taken) within the framework of market surveillance and product control;
- documents that allow tracking the origin of the product and its subsequent circulation (contracts, accompanying documentation, etc.);
- documents and materials on the status of implementation by the business entity of the decision to take restrictive (corrective) measures, including within the monitoring of actions of business entities used by them to withdraw the relevant products from circulation and / or its recall;
- notifications and other information provided by business entities, customs authorities, conformity assessment bodies in accordance with the provisions of this Law and the Law of Ukraine "On General Safety of Non-Food Products";
- other documents and materials, appeals received by market surveillance authorities in accordance with the provisions of this Law and the Law of Ukraine "On General Safety of Non-Food Products".
As you can see the list is quite extensive and will vary depending on the type of product being tested.
The Law also obliges market surveillance authorities to take into account the expert opinions provided by economic entities, product test reports, certificates of conformity or other documents of conformity issued as a result of voluntary conformity assessment by accredited conformity assessment bodies.
What are the terms and procedure for submitting documents?
The law stipulates in several places that the documents regarding the supply chain provided within a period agreed with the market surveillance authority. That is, the authorities cannot unequivocally demand that these documents be provided in a short time. Each company has the right to request an extension of the deadline set by the market surveillance authority for the submission of documents.
There are no deadlines for submitting other documents.
The market surveillance authority may require the submission of original documents, but may seize only copies.
Documents and materials required for market surveillance may be provided in the original language. However, the supervisor may require a translation into Ukrainian. Business entities are obliged to ensure their translation at their own expense within a period not exceeding thirty working days.
In addition to documents, supervisors may also require clarification on issues that arise during the audit. Explanations are also provided within the agreed time.
What after the inspection?
If the market surveillance authority finds that the product poses a serious risk, it may impose the following restrictive (corrective) measures:
1. Restriction of products on the market by:
- bringing products in line with established requirements;
- elimination of formal discrepancies;
- temporary ban on the supply of products on the market.
2. Prohibition of products on the market.
3. Withdrawal of products from circulation.
4. Product recall.
Are there any fines for violations?
In addition to restrictive measures for violations of the Law, liability in the form of fines is also provided. Here are some of them:
|The essence of the violation:
Putting products into circulation, which poses a serious risk
repeated from 1 to 3 years - UAH 85,000
Putting into circulation products that do not meet the established requirements (except for formal non-compliance and serious risk)
repeated during the period from 1 to 3 years - UAH 51,000
The distributor is subject to fines for non-compliance with the storage conditions of the products he distributes, if as a result the products have become dangerous and / or do not meet the established requirements.
repeated within 3 years - UAH 25,500
Non-fulfillment or incomplete fulfillment by manufacturers of the requirements of the decision to take restrictive (corrective) measures (withdrawal, revocation, prohibition)
85 000 грн
Non-fulfillment or incomplete execution of the decision to take restrictive (corrective) measures (elimination of violations that do not pose a serious risk and elimination of formal non-compliance)
51 000 hryvnias
Creation of obstacles by preventing inspections of product characteristics and non-compliance with the requirements established by law for market surveillance officials
170 000 грн
The Law of Ukraine "On General Safety of Non-Food Products" provides for larger fines for certain types of violations.
As we can see, the legislation in the field of non-food safety inspections has been slightly improved, which gives manufacturers and distributors the opportunity to better protect themselves from regulatory authorities. However, increasing the amount of fines can both increase the level of responsibility of economic entities and become a tool of pressure and abuse by regulatory authorities. Therefore, the issue of proper support of the inspection process and its proper documentation from the very beginning of communication with the market surveillance authority remains important.
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The original article is published in the publication Quality management