1. Accreditation and standards
Accreditation is defined in ISO/IEC 17011 as “third party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks”. Accreditation is performed by accreditation bodies and is based on internationally harmonised standards. Accreditation bodies assess the competence of conformity assessment bodies based on the international standards in the ISO/IEC 17000-series, developed by ISO/CASCO.
These standards are the following:
ISO/IEC 17011 Conformity assessment – Requirements for accreditation bodies accrediting conformity assessment bodies
ISO/IEC 17020 Conformity assessment – Requirements for the operation of various types of bodies performing inspection
ISO/IEC 17021 Conformity assessment – Requirements for bodies providing audit and certification of management systems
ISO/IEC 17024 Conformity assessment – General requirements for bodies operating certification of persons
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
ISO/IEC 17029 Conformity assessment – General principles and requirements for validation and verification bodies
ISO/IEC 17034 General requirements for the competence of reference material producers
ISO/IEC 17043 Conformity assessment – General requirements for proficiency testing
ISO/IEC 17065 Conformity assessment – Requirements for bodies certifying products, processes and services
Apart from these there are a number of ISO standards developed by the ISO technical committees which define the competence requirements on certain bodies which are also subject to accreditation.
Some of these are:
ISO 14065 General principles and requirements for bodies validating and verifying environmental information
ISO 15189 Medical laboratories – Requirements for quality and competence
ISO 15195 Laboratory medicine – Requirements for the competence of calibration laboratories using reference measurements procedures
ISO 20387 Biotechnology – Biobanking – General requirements for biobanking
2. Cooperation between accreditation bodies
Accreditation bodies are organized in regional and global cooperation organisations in order to harmonise the implementation of the international standards which they use and in order to harmonise the technical rigour of their assessments. The aim of this harmonization is to make sure that the results produced by accredited CABs around the world are equivalent. This in turn makes it possible to have multilateral agreements for mutual recognition of conformity assessment results. The ultimate goal is to create a fair playing field for all economic actors and to facilitate the elimination of technical barriers to trade related to conformity assessment without increasing the economic burden of the enterprises involved.
There are a number of regional cooperation bodies for accreditation. The regional cooperation body of which TURKAK is a member is EA (European accreditation cooperation). The geographical coverage of EA is Europe and its neighbouring countries. For the name and geographic coverage of other regional cooperation please see the websites of ILAC and IAF.
3. Mutual recognition of accreditations and conformity assessment results
Mutual recognition of accreditations and conformity assessment results is based on procedures which the accreditation bodies within each regional cooperation have agreed on. These procedures invariably require the successful peer-evaluation of each accreditation body. Peer-evaluations are normally performed once every fourth year but can have shorter intervals if necessary. In a peer-evaluation, the accreditation body being evaluated has to prove that it correctly implements the requirements of the international standards and the conditions of the regional cooperation agreement. A successful closure of a peer-evaluation allows an accreditation body to become a signatory of the multilateral agreement of mutual recognition within the regional and global cooperation.
TURKAK has successfully passed the peer-evaluation processes of EA and is a signatory to the EA, ILAC and IAF multilateral agreements of mutual recognition. For more information on this see the websites of TURKAK, EA, ILAC and IAF.
TURKAK´s accreditations are recognized by the members of EA, ILAC and IAF. The results of conformity assessment bodies accredited by TURKAK are also recognised by the members of EA, ILAC and IAF. However, this does not mean that the market in general in any country necessarily has to recognize TURKAK accreditations or conformity assessment results from bodies accredited by TURKAK. The market is free to accept or not to accept such results in the absence of binding agreements between states/economies. Yet, through the hard work of ILAC and IAF and their members more and more markets are recognizing the mutual recognition agreements of ILAC and IAF and accepting results from accredited conformity assessment bodies, also in the absence of binding agreements between the countries.
In order for mutual recognition to be mandatory there has to be a trade or customs agreement between the countries in question. Such an agreement has to cover the conformity assessment topic and mandate the mutual recognition of results. This is the case in Europe. The harmonized legislation of the EU, with which member states have to abide, makes it mandatory for primarily regulators to recognize accreditation bodies which are signatories to the EA agreement and accept results from conformity assessment bodies accredited by EA members independent of the member state in which they are established. EU legislation also promotes the use of the accreditation system and mutual recognition to apply to the voluntary sector where harmonised legislation does not exist. See also chapter on the Customs Union agreement between Turkey and the EU.
4. World Trade Organisation (WTO) and technical barriers to trade
(Based on the website of WTO)
The World Trade Organization (WTO) is the only global international organization dealing with the rules of trade between nations. At its heart are the WTO agreements, negotiated and signed by the bulk of the world’s trading nations and ratified in their parliaments. The goal is to ensure that trade flows as smoothly, predictably and freely as possible.
The WTO has many roles: it operates a global system of trade rules, it acts as a forum for negotiating trade agreements, it settles trade disputes between its members, and it supports the needs of developing countries.
All major decisions are made by the WTO’s member governments: either by ministers (who usually meet at least every two years) or by their ambassadors or delegates (who meet regularly in Geneva).
The WTO agreements are lengthy and complex because they are legal texts covering a wide range of activities. However, a number of simple, fundamental principles run throughout all of these documents. These principles are the foundation of the multilateral trading system.
A country should not discriminate between its trading partners and it should not discriminate between its own and foreign products, services or nationals.
Lowering trade barriers is one of the most obvious ways of encouraging trade; these barriers include customs duties (or tariffs) and measures such as import bans or quotas that restrict quantities selectively.
Predictable and transparent
Foreign companies, investors and governments should be confident that trade barriers should not be raised arbitrarily. With stability and predictability, investment is encouraged, jobs are created and consumers can fully enjoy the benefits of competition — choice and lower prices.
Discouraging ‘unfair’ practices, such as export subsidies and dumping products at below cost to gain market share; the issues are complex, and the rules try to establish what is fair or unfair, and how governments can respond, in particular by charging additional import duties calculated to compensate for damage caused by unfair trade.
More beneficial for less developed countries
Giving them more time to adjust, greater flexibility and special privileges; over three-quarters of WTO members are developing countries and countries in transition to market economies. The WTO agreements give them transition periods to adjust to the more unfamiliar and, perhaps, difficult WTO provisions.
Protecting the environment
The WTO’s agreements permit members to take measures to protect not only the environment but also public health, animal health and plant health. However, these measures must be applied in the same way to both national and foreign businesses. In other words, members must not use environmental protection measures as a means of disguising protectionist policies.
Technical barriers to trade
Exporting enterprises must sometimes incur additional costs as they adapt their production to the changing legal requirements of the recipient country. Such requirements can thus create technical barriers to trade. Discrepancies between product rules adopted by different countries can involve numerous aspects: weight, size, packaging, ingredients, mandatory labelling, shelf-life conditions, testing and certification procedures etc.
Technical barriers to trade (TBTs), a category of nontariff barriers to trade, are the widely divergent measures that countries use to regulate markets, protect their consumers, or preserve their natural resources, among other objectives, but they can also be used or perceived by foreign countries, to discriminate against imports in order to protect domestic industries.
The Technical Barriers to Trade (TBT) Agreement of the World Trade Organisation aims to ensure that technical regulations, standards, and conformity assessment procedures are non-discriminatory and do not create unnecessary obstacles to trade. At the same time, it recognises WTO members’ right to implement measures to achieve legitimate policy objectives, such as the protection of human health and safety, or protection of the environment. The TBT Agreement strongly encourages members to base their measures on international standards as a means to facilitate trade. Through its transparency provisions, it also aims to create a predictable trading environment.
Under the TBT Agreement, it is required that rules which can create or can be perceived as technical barriers to trade are notified to the WTO TBT committee. There are two categories of rules which should be notified:
- Technical regulationslay down mandatory product characteristics or their related processes and production methods. For example: requirements on product size, weight, composition, packaging, marking, labelling.
- Conformity assessment proceduresare any procedure used to determine that the relevant requirements of technical regulations or standards are fulfilled. For example: procedures for sampling, testing, inspection, evaluation, verification and assurance of conformity, registration, accreditation and approval.
The safety requirements are normally put on products through regulations issued by the governments and their agencies. Governments may have bilateral, multilateral and regional agreements through which they harmonise their safety requirements on products and services. A very well-known example for regional agreements on products and services is the EU harmonized technical regulations and directives which are binding for the EU member states and the states with which EU has a trade or customs agreement. EU and Turkey have a customs agreement.
5. Customs agreement between Turkey and the EU
(Based on the Blue Guide, Chapter on Turkey)
Turkey and the EU are important economic partners:
- Turkey is the sixth largest trade partner of the EU. The EU is Turkey’s largest trade partner and major source of foreign direct investment (FDI).
- During 2020, despite the pandemic, Turkey exported to the EU, 62.6 billion EUR worth of goods while importing for 69.9 billion EUR. The overall annual trade volume exceeded for the fourth consecutive year 130 billion EUR.
- Thanks in large part to the EU-Turkey Customs Union, trade between the EU and Turkey has increased more than fourfold over the 24 years of its existence.
- Turkey is an important part of the European value chains particularly in automotive, textiles and machinery.
Turkey and the EU established a Customs Union in 1995 (Decision 1/95 of the EU-Turkey Association Council, 96/142/EC). The Customs Union Decision covers trade in manufactured products and processed agricultural products between Turkey and the EU and entails alignment by Turkey with all EU product legislation. The Agreement aims to ensure the free movement of manufactured products and processed agricultural products between the EU and Turkey, by eliminating import controls at the EU-Turkey border on such products.
Articles 5 to 7 of the Decision provide for the elimination of measures having an effect equivalent to customs duties between the European Union and Turkey, mirroring Articles 34-36 of the Treaty on the Functioning of EU (TFEU). Pursuant to Article 66 of the Decision, its Articles 5 to 7 must, for the purposes of their implementation and application to products covered by the Customs Union Decision, be interpreted in conformity with the relevant case law of the Court of Justice, most notably the Cassis de Dijon case on mutual recognition.
As a consequence, in the sectors for which Turkey has aligned its legislation with that of the EU, a product lawfully manufactured and/or marketed in Turkey should be treated equal to a product lawfully manufactured and/or marketed in the EU and should not be subject to import controls. The same reasoning would apply in the non-harmonised sectors where Turkey has aligned its legislation with Articles 34-36 of the TFEU. The Decision also requires Turkey to adopt European Union legislation on products and on quality infrastructure, notably on CE marking requirements, notified bodies, market surveillance, accreditation, standardisation, metrology and mutual recognition in the non-harmonised area.
Another Decision (Decision No 2/97 of the EC-Turkey Association Council) signed in 1997 lays down the list of the Union’s legal instruments, including part of the acquis on industrial products related to the removal of technical barriers to trade and the conditions and arrangements governing their implementation by Turkey. Annex I to this Decision ensures that when Turkey adopted the legislation listed in Annex II to the Decision, the same rules and procedures would apply in the EU and Turkey for products that fall within the scope of the legislation listed in Annex II to the Decision. However, many of the legislative instruments set out in Annex II have been gradually replaced by new Union directives and regulations.
In 2006, the EU-Turkey Association Council adopted a new Decision (1/2006), providing for the designation of Turkish notified bodies and recognition of the test reports and certificates issued by such bodies in Turkey. The Parties have signed statements confirming that Turkey’s legislation is equivalent to that of the EU for a number of New Approach directives and regulations.
In the non-harmonised area, the rights and obligations of economic operators supplying products to the EU market from Turkey have been laid down in the Commission’s interpretative communication on ‘facilitating the access of products to the markets of other Member States: the practical application of mutual recognition’.
The Turkish Accreditation Agency (TURKAK) is a member of the European cooperation for Accreditation (EA) and is a signatory to all the existing mutual recognition agreements within EA. Certificates issued by Turkish conformity assessment bodies accredited by TURKAK should be deemed equivalent to those issued by conformity assessment bodies established in the EU and accredited by EU National Accreditation Bodies. In the area of standardisation, both CEN and CENELEC granted full membership status to the Turkish Standards Institute (TSE) on 1 January 2012.
6. Harmonization of legislation
There are two essential conditions which facilitate the implementation of the Customs Union Agreement between Turkey and the EU. The first one requires that Turkey incorporates EU technical harmonized legislation in Turkish law. In other words, it requires the harmonisation of Turkish law on products with the EU regulations and directives on product areas listed in the agreement. The second requires that the Turkish quality infrastructure is kept in line with the quality infrastructure of the EU member states.
The requirement on the quality infrastructure is met and the actors of the Turkish quality infrastructure are accepted and respected members of regional and global co-operations.
The requirements on the harmonisation of technical legislation, i.e. incorporation of EU regulations and directives in Turkish law, can sometimes take time due to the legal nature of the process and the necessity to make sure that the EU legislation fits into the Turkish legal framework. The smooth operation of the customs agreement depends on whether EU legislation has been incorporated in Turkish law and implemented by the actors of the Turkish market.
7. The Turkish quality infrastructure
The quality infrastructure of Turkey is well developed and in harmony with the quality infrastructure of developed economies. The Turkish quality infrastructure meets the requirements of the customs agreement with the EU.
The quality infrastructure of an economy is the system comprising the organizations (public and private) together with the policies, relevant legal and regulatory framework, and practices needed to support and enhance the quality, safety and environmental soundness of goods, services and processes.
The quality infrastructure is required for the effective operation of domestic markets, and its international recognition is important to enable access to foreign markets. It is a critical element in promoting and sustaining economic development, as well as environmental and social wellbeing.
It relies on:
- conformity assessment, and
- market surveillance.
In Turkey UME is the national metrology institute, TSE is the standardisation institute and TURKAK is the national accreditation body. Conformity assessment is performed by public and private economic actors which are normally accredited by TURKAK. Market surveillance is the responsibility of the ministries.
8. What is a notified body?
EU legislation in general and the NLF in particular require that conformity assessment within the various product sectors is performed by conformity assessment bodies which may be monitored by the member state in question and necessary measures taken when need arises. To achieve this goal a special type of conformity assessment body has been defined: notified body.
A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. The European Commission publishes a list of such notified bodies and these are searchable on the NANDO data base.
Apart from meeting the requirements of the relevant standards in the EN ISO/IEC 17000-series or any other harmonized EN ISO standard for conformity assessment bodies, a notified body has to meet the additional requirements of the EU legislation as described in the applicable regulation or directive. Such requirements can be technical, legal and administrative. When the notifying authority is convinced that all requirements are met, it may notify the conformity assessment body to the EU, whereby it receives a notified body identity number and is registered in the NANDO data base.
Conformity assessment performed by notified bodies is a service to manufacturers in an area of public interest. It is the responsibility of the EU country to notify conformity assessment bodies within their jurisdiction according to principles laid down in Decision 768/2008/EC.
- are free to offer their conformity assessment services to any economic operator inside or outside the EU
- may carry out these activities on the territory of other EU countries or non-EU countries
- must operate in a non-discriminatory, transparent, neutral, independent, and impartial manner
- must employ the necessary personnel, with sufficient knowledge and experience to carry out the conformity assessment in accordance with the law(s) in question
- must make adequate arrangements to ensure the confidentiality of the information obtained in the course of conformity assessment
- must be adequately insured to cover their professional activities, unless liability is assured under the national legislation of the notifying EU country
- must provide information to their notifying authority, the market surveillance authorities, and other notified bodies.
Manufacturers are free to choose any notified body that has been legally designated to carry out the conformity assessment procedure. (https://ec.europa.eu/growth/single-market/goods/building-blocks/notified-bodies_en)
9. Accreditation as a tool in the appointment of notified bodies
According to EU legislation accreditation is the preferred route for a conformity assessment body to become a notified body within the scope of the harmonised technical legislation unless the regulation or directive in question has defined other provisions. However, the member states are free to choose whether they want to take the accreditation route. For the EU regulations and directives which have been incorporated in Turkish law the Turkish authorities have chosen to rely on accreditation for the assessment of the competence of conformity assessment bodies wishing to become notified bodies. The actual appointment of a notified body and its notification to the NANDO database is made by the appointed ministry/ministries. The member states are accountable for the competence of notified bodies and the quality of the work they perform. Within the EU accreditation bodies are either government agencies or have been delegated the role of being the national accreditation body by their government. This guarantees government control and monitoring for the process of assessment and notification.
10. The Blue Guide on the Implementation of EU product rules
(Based on the Blue Guide)
The Blue Guide was first issued in 2000. This new edition, issued in 2016, builds on the past edition, but includes new chapters, for example on the obligations of economic operators, on accreditation and completely revised chapters such as those on standardisation and market surveillance. The Guide has also been given a new title reflecting the fact that the New Legislative Framework is likely to be used, at least in part, by all types of Union harmonisation legislation and not only by the so-called ‘New Approach’ directives.
This Guide is intended to contribute to a better understanding of EU product rules and to their more uniform and coherent application across different sectors and throughout the single market. It is addressed to the Member States and others who need to be informed of the provisions designed to ensure the free circulation of products as well as a high level of protection throughout the Union (e.g. trade and consumer associations, standardisation bodies, manufacturers, importers, distributors, conformity assessment bodies and trade unions).
This Guide is intended purely as a guidance document — only the text of the Union harmonisation act itself has legal force. In certain cases, there may be differences between the provisions of a Union harmonisation act and the contents of this Guide, in particular where slightly divergent provisions in the individual Union harmonisation act cannot be fully described in this Guide. The binding interpretation of EU legislation is the exclusive competence of the Court of Justice of the European Union. The views expressed in this Guide cannot prejudge the position that the Commission might take before the Court of Justice. Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the information in the Blue Guide.
This Guide applies to the EU Member States but also to Iceland, Liechtenstein and Norway as signatories of the Agreement on the European Economic Area (EEA), as well as Turkey in certain cases. References to the Union or the single market are, accordingly, to be understood as referring to the EEA, or to the EEA market.
Update of the Blue Guide
An update of the Blue Guide (2016) started in 2019 and is currently in progress, with draft revisions identifying a number of areas of change, including:
- aspects of the circular economy such as the remanufacturing and treatment of used goods,
- a more accurate reflection of issues arising in the digital age and under a circular economy,
- certain legal implications of Brexit,
- coherence with the EU’s ongoing enhancement of its market surveillance and enforcement regime, and
- amendments to clarify certain points.
The new version of the Blue Guide is expected to be published during 2021.
11. The New Legislative Framework
The evolution of EU legislative techniques to achieve a free circulation of goods has been progressive, tackling issues one after another and sometimes in parallel, culminating in the adoption of the New Legislative Framework which addresses the following topics:
- essential or other legal requirements,
- product standards,
- standards and rules for the competence of conformity assessment bodies as well as for accreditation,
- standards for quality management,
- conformity assessment procedures,
- CE marking,
- accreditation policy, and lately
- market surveillance policy including the control of products from third countries.
The New Legislative Framework now constitutes a complete system bringing together all the different elements that need to be dealt with in product safety legislation in a coherent, comprehensive legislative instrument that can be used across the board in all industrial sectors, and even beyond (environmental and health policies also have recourse to a number of these elements), whenever EU legislation is required. In this system, the legislation has to set the levels of public protection objectives of the products concerned as well as the basic safety characteristics and it should set the obligations and requirements for economic operators. Where necessary, it has to set the level of competence of the third-party conformity assessment bodies which assess products or quality management systems, as well as the control mechanisms for these bodies for example notification and accreditation. It must determine which are the appropriate conformity assessment processes to be applied, and finally it must impose the appropriate market surveillance mechanisms to ensure that the whole legislative instrument operates in an effective and seamless manner.
All these different elements are interlinked, operate together and are complementary, forming an EU quality chain. The quality of the product depends on the quality of the manufacturing, which in many instances is influenced by the 26.7.2016 EN Official Journal of the European Union C 272/11 quality of testing, internal or carried out by external bodies, which depends on the quality of the conformity assessment processes, which depends on the quality of the bodies which in turn depends on the quality of their controls, which depends on the quality of notification or accreditation; the entire system depending on the quality of market surveillance and controls of products from third countries. They should all be treated in one way or another in any piece of EU product safety legislation. If one element goes missing or is weak, the strength and effectiveness of the entire ‘quality chain’ is at stake.
12. In case of new or revised legislation
(Based on the Blue Guide)
In the case of new or revised legislation, economic operators may be given additional time to adapt to the new rules which is called transitional period and corresponds to the lapse of time between the entry into force of a new rule and the moment it starts applying. Transitional period means that the existing product rules remain applicable although new rules have been already adopted. Transitional period may be introduced by the legislator in the case EU product rules are being revised or come to replace national rules. The aim of the transitional period is to allow manufacturers, national authorities and notified bodies to adjust gradually to the conformity assessment procedures and the essential or other legal requirements set up by a new or a revised piece of legislation, and, thus, to avert the risk of blocking production. Further, manufacturers, importers and distributors need to be given time to exercise any rights they have acquired under any pre-existing, national or EU rules, for example to sell their stocks of products manufactured in line with the pre-existing rules. Finally, the transitional period provides for extra time for the revision and adoption of harmonised standards, even though this is not a precondition for the application of Union harmonisation legislation. Each Union harmonisation legislation providing for a transitional period sets the date for freezing the system in force. Generally, this is the date on which the legislation enters into force, but sometimes it is the date on which the legislation is adopted. After the transitional period, products manufactured before or during this period, in line with the legislation to be repealed, may no longer be placed on the market. A product, which is placed on the market before the end of the transitional period, should be allowed to be made available on the market or put into service. Nevertheless, specific Union harmonisation legislation could forbid the making available of such products if this is deemed necessary for safety reasons or other objectives of the legislation. Products which were not placed on the market before the end of the transposition period can only be placed on the market or put into service, if they fully comply with the provisions of the new legislation. According to the general rule, CE marking is an indication that products, which are subject to one or several pieces of Union harmonisation legislation providing for its affixing, conform to the provisions of all these applicable legislations. However, where one or more of these pieces of legislation allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking is an indication of conformity only to the legal texts applied by the manufacturer. Consequently, during a transitional period, the CE marking does not necessarily indicate that the product conforms to all applicable pieces of legislation providing for its affixing. Information concerning all Union harmonisation legislation applied by the manufacturer has to be found in the EU declaration of conformity.
13. The CE marking
(Based on the Blue Guide)
The CE marking is a key indicator, but not proof, of a product’s compliance with EU legislation and enables the free movement of products within the EEA and Turkish market, whether they are manufactured in the EEA, Turkey or in another country.
- The CE marking indicates the conformity of the product with the Union legislation applying to the product and providing for CE marking.
- The CE marking is affixed on products that will be placed on the EEA and Turkish market, whether they are manufactured in the EEA, in Turkey or in another country.
Member States of the European Economic Area (EEA — EU Member States and certain EFTA countries: Iceland, Norway, Liechtenstein) are not allowed to restrict the placing on the market of CE marked products, unless such measures can be justified on the basis of evidence of the non-compliance of the product. This also applies to products made in third countries which are sold in the EEA. CE marking does not indicate that a product was made in the European Union. The CE marking indicates conformity with the requirements laid down by the Union harmonisation text(s) in question. Therefore, it is to be considered as essential information to Member States’ authorities as well as other relevant parties (for example distributors). CE marking does not serve commercial purposes, i.e. it is not a marketing tool. CE marking is the visible consequence of a whole process comprising conformity assessment in a broad sense and indicates that a product is declared by the manufacturer as in conformity with Union harmonisation legislation.