Machinery Safety Directive 2006/42/EC Conformity Assessment

FQC STANDARD ACCREDITATION AND AUTHORISATIONS UNDER THE MACHINERY SAFETY DIRECTIVE 2006/42/EC

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 Machinery Safety Directive 2006/42/EC.

WHAT IS THE PURPOSE OF THE MACHINERY SAFETY DIRECTIVE 2006/42/EC?

The machinery sector is a major part of the engineering industry and an important industrial foundation of the economy. The social cost of accidents directly associated with machinery use can be reduced through safe design and construction, correct installation and proper maintenance. A harmonised regulatory framework for machinery design and manufacture therefore helps eliminate many risks.

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 EC declaration of conformity and affix the CE mark. Only then may the product be traded in the EEA market.

The Machinery Safety Directive 2006/42/EC harmonises the health and safety requirements applicable to machinery, providing a high level of protection while enabling machinery to be placed on the market safely and circulate freely within the EU.

The directive establishes essential safety requirements for machinery design and manufacture so that machinery may be placed on the market and put into service without endangering people or, where appropriate, domestic animals and property, when correctly installed, maintained and used for its intended purpose.

The CE mark indicates that the machinery complies with all applicable provisions of Directive 2006/42/EC requiring the manufacturer to affix that mark.

WHAT IS THE CONFORMITY ASSESSMENT SCOPE OF DIRECTIVE 2006/42/EC?

The directive covers machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices, and partly completed machinery.

To demonstrate conformity with Directive 2006/42/EC, the manufacturer or its authorised representative applies one of the following conformity assessment procedures:

1. TABLE 1

   Conformity Assessment through Internal Checks

   If your machinery is not listed in Table 1 below, the manufacturer or its authorised representative must prepare the technical file described in Table 2 for each representative type in the series and declare that the machinery has been manufactured in accordance with Directive 2006/42/EC, with all necessary measures taken.

   No	Machinery Categories
   1	The following types of circular saw, with one or more blades, for working wood and materials with similar physical characteristics, or meat and materials with similar physical characteristics:
   1.1	Sawing machinery with blades fixed during cutting, a fixed bed or support, and manual workpiece feed or a removable power-feed device;
   1.2	Sawing machinery with blades fixed during cutting and a manually operated reciprocating saw bench or carriage;
   1.3	Sawing machinery with blades fixed during cutting, an integrated mechanical workpiece-feed device, and manual loading or unloading;
   1.4	Sawing machinery with blades that move mechanically during cutting and with manual loading or unloading;
   2	Hand-fed surface-planing machinery for woodworking;
   3	Thicknessing planers for single-side dressing of wood, with an integrated mechanical feed device and manual loading or unloading;
   4	The following types of band saw with manual loading or unloading, for working wood and similar materials, or meat and materials with similar physical characteristics:
   4.1	Sawing machinery with blades fixed during cutting and a fixed or reciprocating bed or support for the workpiece;
   4.2	Sawing machinery with blades mounted on a reciprocating carriage;
   5	Combined woodworking machines of the types referred to in paragraphs 1 to 4 and 7 above, for wood and materials with similar physical characteristics;
   6	Hand-fed tenoning machinery with several tool holders for woodworking;
   7	Vertical-spindle moulding machinery for wood and materials with similar physical characteristics;
   8	Portable chainsaws for woodworking;
   9	Presses, including press brakes, for cold working metals, with manual loading or unloading, where moving working parts have a travel exceeding 6 mm and a speed exceeding 30 mm/s;
   10	Injection or compression plastics-moulding machinery with manual loading or unloading;
   11	Injection or compression rubber-moulding machinery with manual loading or unloading;
   12	The following machinery for underground work:
   12.1	Locomotives and narrow-gauge rail vehicles;
   12.2	Hydraulically powered roof supports;
   13	Manually loaded refuse-collection vehicles incorporating a compression mechanism;
   14	Removable mechanical transmission devices and their guards;
   15	Guards for removable mechanical transmission devices;
   16	Vehicle servicing lifts;
   17	Devices for lifting people, or people and goods, where there is a risk of falling from a vertical height of more than three metres;
   18	Portable cartridge-operated fixing machinery and other impact machinery;
   19	Protective devices designed to detect the presence of people;
   20	Power-operated, interlocking movable guards designed to protect users of the machinery listed in paragraphs 9, 10 and 11;
   21	Logic units for safety functions;
   22	Roll-over protective structures (ROPS);
   23	Falling-object protective structures (FOPS).

   TABLE 2

   TECHNICAL DOCUMENTATION CONTENTS

   The technical file explains the product's design, manufacture and operation. Directive 2006/42/EC requires the manufacturer to prepare a file demonstrating conformity with the applicable requirements. It must describe the product and its intended use and cover design, manufacture and operation. Adequate risk analysis requires the manufacturer to identify all potential risks and determine the relevant essential requirements. The analysis must be documented and included in the file. The manufacturer must also explain how the identified risks have been addressed. Where a harmonised standard is applied only in part, or does not cover every applicable essential requirement, the file must document how the remaining requirements are met.

   No	Description
   1	Cover Page
   2	Contents
   3	Manufacturer Information
   4	A general description and identification of the machinery.
   5	An overall drawing of the machinery and drawings of its control circuits, with the descriptions and explanations needed to understand its operation.
   6	Detailed drawings, calculations, test results and documentation necessary to verify compliance with the essential health and safety requirements.
   7	Risk assessment documentation showing the procedures followed, including a list of the applicable essential health and safety requirements, a description of protective measures used to eliminate hazards or reduce risks, and any residual risks associated with the machinery.
   8	The standards and other technical specifications used, indicating the essential health and safety requirements they cover.
   9	Technical reports containing test results obtained by the manufacturer or by an organisation selected by the manufacturer or its authorised representative.
   10	A copy of the machinery instructions.
   11	Where applicable, the declaration of incorporation for partly completed machinery and its assembly instructions.
   12	Where applicable, copies of EC declarations of conformity for the machinery and other products incorporated into it.
   13	A copy of the EC declaration of conformity (Table 3).

   TABLE 3

   EC DECLARATION OF CONFORMITY

   An EC declaration of conformity states that a product meets all applicable legislative requirements. Directive 2006/42/EC requires the manufacturer or its authorised representative to prepare and sign the declaration before placing the product on the market. By preparing and signing it, the manufacturer assumes responsibility for conformity. A written declaration is prepared for each model and retained for 10 years after the product is placed on the market, so that it can be supplied to the Ministry on request. The declaration must identify the model to which it relates.

   No	Contents
   1	The business name and full address of the manufacturer and, where applicable, its authorised representative.
   2	The name and address of the person authorised to compile the technical file, who must be established in Türkiye or the Community.
   3	A description and identification of the machinery, including its model designation, function, model, type, serial number and commercial name.
   4	An explicit statement that the machinery complies with the relevant provisions of 2006/42/EC and, where applicable, similar statements of conformity with other relevant regulations or provisions.
   5	Where applicable, the name, address and identification number of the notified body that performed the EC-type examination under Annex IX, and the number of the EC-type examination certificate.
   6	Where applicable, the name, address and identification number of the notified body that approved the full quality assurance system under Annex X.
   7	References to the harmonised standards used.
   8	References to other technical standards and specifications used.
   9	The place and date of the declaration.
   10	The identity and signature of the person authorised to prepare the declaration on behalf of the manufacturer or its authorised representative.
   11	A copy of the notified body's CE certificate.

2. CE MARKING — Conformity Assessment with FQC STANDARD as Notified Body

   

   If your machinery is listed in Table 1 above:

   The applicable procedure depends on Article 12 of Directive 2006/42/EC. For Annex IV machinery fully covered by relevant harmonised standards, internal production checks are one permitted route; EC-type examination with internal production checks or full quality assurance are alternatives. Where those standards are absent, incomplete or not fully applied, notified body involvement is required through EC-type examination or full quality assurance. After successful assessment, the manufacturer affixes the CE mark. The notified body's identification number follows the mark when the full quality assurance procedure under Annex X is used. The notified-body assessment routes are outlined below.

Certification through Annex IX EC-Type Examination under Directive 2006/42/EC

For machinery listed in Table 1, FQC STANDARD examines the technical file and supporting evidence described in Table 2 and assesses a representative sample of the intended production. The assessment verifies and approves that the technical design meets Directive 2006/42/EC. The Annex IX EC-type examination certificate is valid for 5 years.

Certification through Annex X Full Quality Assurance under Directive 2006/42/EC

This procedure applies to machinery listed in Table 1 that is manufactured under a full quality assurance system. FQC STANDARD examines the technical file and supporting evidence in Table 2 and the technical design of a representative production sample, verifies conformity with Directive 2006/42/EC, and assesses, approves and monitors the quality system. The Annex X full quality assurance certificate is valid for 3 years, subject to annual surveillance verification.

WHEN IS MACHINERY CERTIFICATION MANDATORY, AND HOW IS IT ENFORCED?

Türkiye's Machinery Safety Regulation 2006/42/EC was published in Official Gazette No. 27158 on 3 March 2009.

For market surveillance of products under 2006/42/EC, 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 a product presents a risk to people, domestic animals or property, it assesses the product against all relevant requirements. If nonconformity is found, the Ministry promptly requires the relevant economic operator — manufacturer, authorised representative, importer or distributor — to take 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.