Gas Appliances Regulation 2016/426/EU Regulation
FQC STANDARD provides conformity assessment, CE marking and certification services for gas appliances and fittings under TÜRKAK accreditation and European Commission notified body authorisation.
Page Contents
- Accreditation and authorisation information
- Purpose and scope of the regulation
- Mandatory certification and enforcement measures
- Overview of Modules B, C2, D, E, F and G
- Contents of the technical file and EU declaration of conformity
FQC STANDARD Accreditation and Authorisations
FQC STANDARD holds Turkish Accreditation Agency (TÜRKAK) accreditation under file number AB-0122-U to TS EN ISO/IEC 17065, Conformity Assessment — Requirements for Bodies Certifying Products, Processes and Services. It is also authorised to perform CE-marking conformity assessment services with European Commission notified body identification number 2674.
Current accreditation and authorisation details can be checked on the official websites of the Turkish Accreditation Agency and the European Commission. FQC STANDARD holds TÜRKAK accreditation and European Commission notified body authorisation under the Gas Appliances Regulation 2016/426/EU.
What Is the Purpose of the Gas Appliances Regulation 2016/426/EU?
Manufacturers play a vital role in ensuring that products supplied to the extended single market of the European Economic Area (EEA) are safe. They are responsible for checking compliance with EU safety, health and environmental protection requirements. The manufacturer must arrange conformity assessment, compile the technical file, prepare the EU declaration of conformity and affix the CE mark. Only then may the product be traded in the EEA market.
The Gas Appliances Regulation 2016/426/EU aims to ensure that gas appliances and fittings are placed on the EU market or put into service safely and reliably, without endangering people, domestic animals or property when used normally. The CE mark indicates that the appliance or fitting complies with all applicable provisions of the regulation requiring that mark to be affixed by the manufacturer.
What Is the Certification Scope under 2016/426/EU?
Before appliances covered by the Gas Appliances Regulation 2016/426/EU are placed on the European market, the essential requirements in Annex I require them to be designed and manufactured for safe operation without creating hazards.
The regulation covers appliances burning gaseous fuels for cooking, heating, air conditioning, hot-water production, refrigeration, lighting or washing. It also covers fittings: safety, controlling or regulating devices and their subassemblies designed to be incorporated into an appliance.
When Is Certification Mandatory, and How Is It Enforced?
Regulation (EU) 2016/426 of the European Parliament and of the Council, dated 31 March 2016, repealed Directive 2009/142/EC on gas appliances and became mandatory from 21 April 2018.
For market surveillance of appliances and fittings under 2016/426/EU, the Ministry of Industry and Technology applies the Regulation on Market Surveillance and Inspection of Products, introduced by Council of Ministers Decision No. 2001/3529 of 13 November 2001. Where it has sufficient reason to believe that an appliance or fitting presents a risk to human health and safety, domestic animals or property, the Ministry assesses it against all relevant requirements of the Gas Appliances Regulation.
If that assessment finds that the appliance or fitting does not meet the regulation's requirements, the Ministry promptly requires the relevant economic operator to take appropriate corrective action, proportionate to the risk. This may involve bringing the product into conformity, withdrawing it from the market or recalling it within a reasonable period.
Which Certification Module Applies to My Product?
Annex III.1, Module B — EU-Type Examination: Production Type
Module B, EU-type examination, is a conformity assessment procedure for a product group in which the technical design of an appliance or fitting is examined, verified and approved as meeting the requirements of the Gas Appliances Regulation 2016/426/EU.
Annex III.2, Module C2 — Conformity to Type Based on Internal Production Control and Supervised Product Checks at Random Intervals
Following Module B EU-type examination, Module C2 is the part of the conformity assessment procedure in which the manufacturer ensures and declares, under its sole responsibility, that the appliances or fittings conform to the type described in the Module B certificate and meet the requirements of Regulation 2016/426/EU. It is based on internal production control and supervised product checks at random intervals.
Annex III.3, Module D — Conformity to Type Based on Quality Assurance of the Production Process
Following Module B EU-type examination, Module D is the part of the conformity assessment procedure in which the manufacturer ensures and declares, under its responsibility, that the appliances or fittings conform to the type described in the Module B certificate and meet Regulation 2016/426/EU. It is based on quality assurance of the production process.
Annex III.4, Module E — Conformity to Type Based on Product Quality Assurance
Following Module B EU-type examination, Module E is the part of the conformity assessment procedure in which the manufacturer ensures and declares, under its responsibility, that the appliances or fittings conform to the type described in the Module B certificate and meet Regulation 2016/426/EU. It is based on product quality assurance.
Annex III.5, Module F — Conformity to Type Based on Product Verification
Following Module B EU-type examination, Module F requires the manufacturer to fulfil the obligations in Annex III, sections 5.2, 5.5.1 and 5.6, of Regulation 2016/426/EU. Subject to section 5.3, the manufacturer ensures and declares, under its sole responsibility, that the appliances or fittings conform to the type described in the Module B certificate and meet the applicable requirements of the regulation.
Annex III.6, Module G — Conformity Based on Unit Verification
Unit verification is a conformity assessment procedure for an individual product. The manufacturer fulfils the obligations concerning technical documentation, production, CE marking and the declaration of conformity, and ensures and declares, under its sole responsibility, that the verified appliance or fitting meets Regulation 2016/426/EU.
Under Module G EU unit verification, the manufacturer or its authorised representative established in Türkiye declares and guarantees that a single product or a small number of products meet the essential requirements of Regulation 2016/426/EU, and that conformity is verified.
What Is a Technical File, and What Does It Contain?
The technical file provides information about a product's design, manufacture and operation. The Gas Appliances Regulation 2016/426/EU requires the manufacturer to prepare a file containing the information needed to demonstrate compliance with the applicable requirements.
As a general rule, the file must describe the product and its intended use and cover its design, manufacture and operation. The requirement for adequate risk analysis and assessment means that the manufacturer must first identify all potential risks and determine the applicable essential requirements. This analysis must be documented and included in the technical file.
The manufacturer must also document how the identified risks have been addressed to ensure compliance with the applicable essential requirements. Where only part of a harmonised standard is applied, or it does not cover every applicable requirement, the file must explain how the remaining essential requirements have been addressed.
Technical File
| No | Contents |
|---|---|
| 1 | Design documentation must enable assessment of the appliance or fitting against the relevant regulatory requirements and include adequate risk analysis and assessment. |
| 2 | A general description of the appliance or fitting. |
| 3 | Conceptual designs, manufacturing drawings, and diagrams of components, subassemblies and circuits. |
| 4 | Risk analysis. |
| 5 | Design calculations, examinations and their records. |
| 6 | Test reports. |
| 7 | Installation and operating instructions for the appliance. |
| 8 | Approval certificates for fittings incorporated into the appliance. |
| 9 | An EU declaration of conformity, together with instructions explaining how the fittings are to be incorporated or assembled to form an appliance. |
| 10 | Test samples. The notified body may request additional samples where necessary. |
| 11 | Any accredited test results held by the manufacturer for use in conformity assessment. |
What Is an EU Declaration of Conformity, and What Does It Contain?
An EU declaration of conformity states that a product meets all applicable requirements of the relevant legislation. Regulation 2016/426/EU requires the manufacturer to prepare and sign this declaration before placing the product on the market.
The manufacturer or its authorised representative must prepare and sign an EU declaration of conformity under Regulation 2016/426/EU. By doing so, the manufacturer assumes responsibility for the product's conformity.
The manufacturer prepares a written EU declaration of conformity for each appliance or fitting model and retains it for 10 years after the product is placed on the market, making it available to the Ministry on request. The declaration must identify the model to which it relates.
EU Declaration of Conformity
| No | Contents |
|---|---|
| 1 | Appliance or fitting, or appliance or fitting model: product, type, batch or serial number. |
| 2 | The manufacturer's name and address and, where applicable, those of its authorised representative. |
| 3 | A statement that the declaration of conformity is issued under the manufacturer's sole responsibility. |
| 4 | The object of the declaration: a description identifying the appliance or fitting for traceability, with an image where necessary for identification. |
| 5 | A statement that the object of the declaration identified in item 4 complies with the relevant EU harmonisation legislation, with references to any other applicable EU legislation. |
| 6 | References to the relevant harmonised standards or other technical specifications applied in support of conformity. |
| 7 | Where a notified body is involved, its name and identification number, together with a reference to the relevant certificate, if applicable. |
| 8 | For fittings, instructions explaining how they are to be incorporated or assembled into an appliance to facilitate compliance with the essential requirements applicable to the finished appliance. |
| 9 | Additional information, where applicable. |
| 10 | The name, surname, position and signature of the authorised person or the person signing on their behalf. |
| 11 | Place and date of issue. |