General Product Safety Regulation

11 March 2021 THURSDAY

Official Gazette

Issue : 31420

REGULATION

From the Ministry of Trade:

GENERAL PRODUCT SAFETY

REGULATION

PART ONE

Purpose, Scope, Basis and Definitions

Purpose

ARTICLE 1 – (1) The purpose of this Regulation is to ensure the safety of products that are placed on the market, made available on the market or supplied and made ready for use by the consumer, that are intended for the consumer or, even if not intended for the consumer, are likely to be used by the consumer under reasonably foreseeable conditions, and to determine the duties of the competent authorities in this field and the obligations of producers and distributors.

Scope

ARTICLE 2 – (1) This Regulation shall apply in cases where there is no technical regulation concerning products or, even if there is a technical regulation, it does not contain provisions on human health and safety or does not contain provisions on certain risks or risk categories.

(2) This Regulation shall apply to all new, used or reconditioned products that are placed on the market, made available on the market or supplied and made ready for use by the consumer, that are intended for the consumer or, even if not intended for the consumer, are likely to be used by the consumer under reasonably foreseeable conditions.

(3) This Regulation shall apply to all products regardless of the selling technique, including sales made through electronic sales and other means of distance communication.

(4) This Regulation shall apply to products offered to consumers in the course of a service. It does not cover equipment used or operated by service providers serving the consumer.

(5) This Regulation shall not apply to used products supplied as antiques or as products to be repaired or reconditioned prior to being used, provided that the supplier clearly informs the person to whom he supplies the product to that effect.

Basis

ARTICLE 3 – (1) This Regulation has been prepared on the basis of Article 24 of the Law on Product Safety and Technical Regulations dated 5/3/2020 and numbered 7223 and Article 455 of Presidential Decree No. 1 on the Organisation of the Presidency published in the Official Gazette dated 10/7/2018 and numbered 30474.

Definitions

ARTICLE 4 – (1) In this Regulation;

a) Ministry: means the Ministry of Trade (General Directorate of Product Safety and Inspection),

b) Serious risk: means any risk requiring urgent intervention by the competent authorities, including risks whose effects do not appear in the short term,

c) Distributor: means the natural or legal person in the supply chain having the status of distributor within the scope of Law No. 7223, whose activities do not affect the safety properties of the product,

ç) Recall: means any measure aimed at achieving the return of a dangerous product that has been supplied or made available to the consumer by the producer or distributor,

d) Safe product: means a product which, under normal and reasonably foreseeable conditions of use, including duration and, where applicable, requirements for putting into service, installation and maintenance, does not present any risk or presents only the minimum risks compatible with the product's use, and which is considered to provide a high level of protection for human health and safety, taking into account the following elements;

1) The characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance.

2) The effect on other products, where it is reasonably foreseeable that it will be used with other products.

3) The presentation of the product, its labelling, warnings and instructions for its use and disposal, and any other information and indications regarding the product.

4) The categories of consumers at risk when using the product, in particular children, persons with disabilities and the elderly.

e) Law: means the Law on Product Safety and Technical Regulations dated 5/3/2020 and numbered 7223,

f) Withdrawal: means any measure aimed at preventing the distribution, offer and display of a dangerous product to consumers,

g) Dangerous Product: means a product that does not meet the definition of safe product,

ğ) Producer;

1) Where established in Türkiye, the natural or legal person having the status of manufacturer within the scope of the Law, who manufactures the product and presents himself as its manufacturer by affixing to the product his name, trademark or any other distinctive mark, or who reconditions the product,

2) Where the manufacturer is not established in Türkiye, the natural or legal person established in Türkiye having the status of authorised representative of the product within the scope of the Law, or, in the absence of an authorised representative, the natural or legal person who imports the product and has the status of importer within the scope of the Law,

3) The natural or legal person in the supply chain having the status of economic operator within the scope of the Law, whose activities may affect the safety properties of a product,

h) Product: means any new, used or reconditioned substance, preparation or article intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them, which is supplied or made available, whether in the course of commercial activities or otherwise,

shall have the meanings indicated above.

PART TWO

General Product Safety

Product safety and general product safety requirements

ARTICLE 5 – (1) Products must be safe.

(2) A product that complies with the provisions on human health and safety of the technical regulations prepared in accordance with the third paragraph of Article 4 of the Law shall be deemed safe until proven otherwise.

(3) The possibility of achieving a higher level of safety or the availability of other products presenting a lesser degree of risk on the market shall not mean that a product is dangerous.

(4) Without prejudice to the provisions of Decision No. 1/95 of the Türkiye-European Union Association Council, and provided that it falls within the scope of the Regulation on Mutual Recognition in the Non-Harmonised Area put into force by the Council of Ministers Decision dated 2/5/2012 and numbered 2012/3169, a product lawfully manufactured or released for free circulation in a member state of the European Union shall be deemed safe, even if it has been produced according to technical regulations, standards or quality rules different from those applied in Türkiye.

(5) In cases where there is no technical regulation concerning the product, or it does not contain provisions on human health and safety, or does not contain provisions on certain risks or risk categories, a product that complies with national standards corresponding to European standards on product safety whose reference numbers have been published in the Official Journal of the European Union shall be deemed safe.

(6) In cases where there is no technical regulation concerning the product, or it does not contain provisions on human health and safety or on certain risks or risk categories, and where the standards referred to in the fifth paragraph do not exist, the conformity of a product with the general product safety requirements shall be assessed by taking into account the following elements, where they exist:

a) National standards corresponding to European standards other than those referred to in the fifth paragraph.

b) National and international standards.

c) Opinions of the competent authorities or of the European Commission serving as guidelines in the assessment of product safety.

ç) Codes of good practice on product safety in force in the sector concerned.

d) The state of technical knowledge and technology.

e) The reasonable expectations of consumers concerning safety.

(7) Conformity of a product with the assessment criteria set out in the fifth and sixth paragraphs shall not prevent the taking of the measures of stopping the placing on the market of the product, preventing its availability on the market, withdrawing it from the market or recalling it, and the application of the sanctions provided for in the provisions of the Law and this Regulation, where the competent authority is of the opinion that, despite such conformity, there are sufficient grounds that the product is dangerous.

PART THREE

Obligations of Producers and Distributors and Powers

and Responsibilities of Competent Authorities

Obligations of producers

ARTICLE 6 – (1) Producers may place on the market or make available on the market only safe products.

(2) Producers, within the limits of their respective activities;

a) Except where it is justified not to do so, shall ensure that the model, batch or serial number of the product or other information enabling it to be identified, together with their name, registered trade name or trademark and the full address at which they can be contacted, are indicated on the product or its packaging in an easily visible and legible manner.

b) Where possible, shall carry out sample testing of the products they place on the market and make available on the market, carry out investigations, keep a register of complaints, dangerous products and recalled products, and keep distributors informed of such monitoring activities.

c) Shall ensure that consumers are adequately and effectively warned about the risks posed by the product.

ç) In cases where the risks posed by the product cannot be clearly understood due to the absence of adequate warnings, shall provide consumers with the necessary information on the risks posed by the product throughout its normal or reasonably foreseeable period of use so as to enable them to assess the risks the product may present, and shall take the necessary measures against these risks.

d) Shall take the necessary measures to avoid the risks posed by products, including the measures of stopping the placing on the market of these products, preventing their availability on the market, withdrawing them from the market or recalling them from consumers. The measure of recalling the product shall be resorted to where other measures are insufficient to prevent the risk.

e) Shall cooperate, when requested by the competent authorities, in measures aimed at preventing the risks posed by the products they supply.

f) After taking the necessary corrective measures within the scope of this Regulation regarding products posing a risk, either on their own initiative or at the request of the competent authority, shall announce information on these measures and on the risks contained in the product in an effective manner by ensuring that consumers are adequately and effectively warned about the risks posed by the product, and shall take into account accessibility for persons with disabilities depending on the scope of the announcement. The announcement shall contain at least the following information:

1) The brand, model or type name or other distinctive features identifying the product.

2) If possible, a photograph or pictorial description of the product.

3) The measure taken.

4) A clear and understandable description of the problem requiring the measure.

5) The name, address and other contact details of the responsible producer.

6) The methods recommended to avoid the risk or to remedy the problem.

(3) The fulfilment by producers of the warning obligation set out in subparagraphs (c) and (ç) of the second paragraph shall not exempt the producer from fulfilling the other obligations set out in this Regulation.

(4) Producers may take the measures set out in the second paragraph voluntarily on their own initiative before the inspection to be carried out by the competent authority, and shall also carry them out at the request of the competent authority.

Obligations of distributors

ARTICLE 7 – (1) Distributors, within the limits of their respective activities;

a) Shall cooperate effectively with producers and competent authorities. In particular, within the scope of the measures taken to prevent risks, they shall inform the producer and the competent authority within the scope of Article 9 in every case where the product poses a risk. They shall keep the documents necessary for tracing the origin of the product and submit them to the competent authority upon request. They shall promptly carry out the instructions of the competent authority.

b) Shall act in a manner that helps ensure compliance with the general product safety requirements by not supplying products which they know or should have known, on the basis of the information in their possession and as professionals, do not comply with the provisions of this Regulation.

c) Are obliged to pass on the information notified to them by the producer regarding the risks and measures related to the product to the next distributor in the supply chain, if any, and to place the announcement referred to in subparagraph (f) of the second paragraph of Article 6 in places where their customers can easily see or access it.

Powers and responsibilities of competent authorities

ARTICLE 8 – (1) In cases where there is no technical regulation concerning the product groups for which they are responsible, or where the technical regulations do not contain provisions on human health and safety or on certain risks or risk categories, competent authorities shall ensure that producers and distributors comply with the obligations set out in this Regulation so that products are safe.

(2) The inspection of the conformity of products with the general product safety requirements shall be carried out, within the framework of the Law and the provisions of the Regulation on Market Surveillance and Inspection of Products put into force by the Council of Ministers Decision dated 13/11/2001 and numbered 2001/3529, by the competent authorities made responsible on the basis of product groups under the provisions of the relevant legislation.

(3) Where more than one competent authority is responsible for a product group under the provisions of the relevant legislation, the inspection of conformity with the general product safety requirements shall be carried out in coordination by all relevant authorities within their responsibilities. Where doubt arises among the competent authorities as to which authority shall apply the inspection and administrative sanctions concerning the product, the signing of a cooperation protocol among the competent authorities to determine the distribution of duties may be preferred.

(4) In cases where, as set out in the third paragraph, more than one competent authority is responsible for the inspection of the conformity of a product group with the general product safety requirements, if a dispute arises among the competent authorities regarding their areas of responsibility, the decision on the resolution of the dispute shall be taken by the Market Surveillance and Inspection Coordination Board established under the Regulation on Market Surveillance and Inspection of Products.

(5) In cases where no competent authority is responsible for the inspection of the conformity of a product group with the general product safety requirements, the decision as to which competent authority should assume responsibility shall be taken by the Market Surveillance and Inspection Coordination Board established under the Regulation on Market Surveillance and Inspection of Products, on the principle that similar products requiring similar safety assessments are inspected by the same competent authority.

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