The European co-operation for Accreditation (EA) has been appointed by the European Commission (EC) as the official European accreditation infrastructure. The appointment of EA follows the adoption of Regulation (EC) No 765/2008 by the European Parliament and the European Council which establishes the legal framework for accreditation in the EU and sets out the requirements for accreditation and market surveillance.
This regulation came into effect from 1st January 2010.
The Regulation promotes a harmonized approach to accreditation in the EU Member States so that, ultimately, one accredited certificate (or report) should be sufficient to demonstrate the technical competence of the accredited Conformity Assessment Bodies.
This is how the concept “accredited once, accepted everywhere” works.
Cooperation between EA and the European authorities is based on the General Guidelines for Cooperation. These Guidelines establish a common understanding of the importance of accreditation for the European economy and life of European citizens and of its supporting role for several European policies and legislation reflecting public interest, notably in the implementation of Community harmonisation legislation.
EA and the EC cooperate very closely to draw up sound and effective regulations. The main communication channel is the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW), which is a Member of the EA Advisory Board and observer of the Multilateral Agreement Council and Horizontal Harmonization Committee. Representatives of EC DG GROW are also invited to attend the EA General Assembly meetings.
Recently, EA has started to develop new services to assist the EC in negotiating trade agreements. The role of EA is to ensure that the technical content of the agreements gives confidence to all parties ensuring real and sustainable mutual benefit while offering sustainable opportunities for growth to European CABs and Industry. The Comprehensive Economic and Trade Agreement with Canada (CETA) is an example.
European Accreditation infrastructure
The EU Regulation (EC) No 765/2008 provides a legal framework for the provision of accreditation services across Europe, highlighting the importance of accreditation for the EU market.
The main principles of accreditation as set out in the Regulation are:
- A service of general interest
- Public authority
- Last level of control conformity assessment
- Voluntary and mandatory fields
- Mandate of the government
- Full compliance with applicable rules
- Accountability to stakeholders
- No predominance of any single interest group
- Non-profit distributing
- No competition
The Regulation identifies the European co-operation for Accreditation (EA) as the sole association entrusted to manage accreditation at European level and defines its responsibilities and obligations in this respect. It places an obligation on EU Member States to accept the results issued by the Conformity Assessment Bodies accredited by any of the EA MLA signatories.
It is part of the “New European Legislative Framework” (NLF) that significantly contributed to the development of the Single Market. The NLF provides transparent rules for the accreditation of Conformity Assessment Bodies. This common legal framework enhances the quality and confidence in the products placed on the EU Market, based on a harmonized approach of conformity assessment.
The success of the European standardisation system in removing technical barriers to trade plays a vital role in ensuring the free movement of goods between EU Member States.
Included in the legislation are requirements regarding the assessment of Conformity Assessment Bodies applying for notification. A Notified Body, in the European Union, is a Conformity Assessment Body that has been formally appointed by a national authority to assess whether a product, its design or its manufacture meet certain standards – usually those relating to specific European regulations or directives.
The process of achieving notification has changed such that accreditation is now the preferred route by which a Conformity Assessment Body demonstrates its competence to become a Notified Body. EA is working continuously to support and harmonise the implementation of the rules for Conformity Assessment Bodies seeking accreditation for notification purposes.
EA-2/17 EA Document on Accreditation for Notification purposes reflects the outcome of the so-called “Accreditation for Notification” project which aims to determine the list of Preferred Conformity Assessment Standards for each Regulation/Directive and Module. The identified standards are meant to be used by EA Members as an EA recommendation for Notified Bodies’ accreditation.
It is important that National Accreditation Bodies (NAB) maintain the confidence of all stakeholders and regulators. This is why they are themselves regularly assessed by their peers in order to ensure their technical competency and impartiality. This peer evaluation process must remain transparent and accepted by all, including national authorities, and tailored to accommodate the specific needs of regulatory sectors.
General Guidelines for Cooperation: on 1 April 2009, the General Guidelines for the Cooperation between EA, the EC, EFTA, and competent national authorities were signed. These Guidelines establish a common understanding of the importance of accreditation for the European economy and life of European citizens and of its supporting role for several European policies and legislation reflecting public interest, notably in the implementation of Community harmonisation legislation. Click HERE to read the General Guidelines for Cooperation
Framework Partnership Agreements: every four years, EA, the European Commission (EC) and the European Free Trade Association (EFTA) sign an agreement, called the Framework Partnership Agreement (FPA). The FPA defines the respective roles and responsibilities of the EC/EFTA and EA in implementing their partnerships. Every year, EA and the EC/EFTA agree on an annual action plan and the associated budget supported by EC and EFTA financing.
Cooperation with directorate-generals
EA is very active with a great number of DGs of the EC. EA’s input is to ensure that accreditation and conformity assessment is used in accordance with Regulation (EC) No 765/2008 and the applicable harmonized standards for accreditation.
Reliance on EA as the main technical focus point is one of the major keystones to strengthen harmonization of accreditation.
EA cooperates, inter alia, with the following Directorate-Generals:
Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW)
- Regulation on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles
- Construction Product Regulation (CPR)
- Regulatory framework for operation of drones
- EGNOS Enable certification scheme for GPS developments and applications
- EA reports to the Expert Group on the Internal Market for Products (IMP).
Directorate-General for Climate Action (DG CLIMA)
- Regulation (EU) 2015/757 on the monitoring, reporting and verification of carbon dioxide emissions from maritime transport (MRV) and Commission Delegated Regulation (EU) 2016/2072 on the verification activities and accreditation of verifiers pursuant to Regulation (EU) 2015/757 of the European Parliament and of the Council on the monitoring, reporting and verification of carbon dioxide emissions from maritime transport.
- Commission Regulation (EU) No 600/2012 on the verification of greenhouse gas emission reports and tonne-kilometre reports and the accreditation of verifiers pursuant to Directive 2003/87/EC.
Directorate-General for Health and Food Safety (DG SANTE)
- Guidelines for accreditation in the field of pesticide residues analyses in food and feed.
Directorate-General for Employment, Social Affairs and Inclusion (DG EMPL)
- Example: Involvement in the ESCO (European Skills/Competence, qualifications and Occupations) project to highlight the benefits of accreditation to guarantee competence and confidence in accredited bodies performing conformity assessment services such as certifications of persons (welders, IT expert, auditors, data protection officers, etc.).
Directorate-General for Mobility and Transport (DG MOVE)
- Example: Project managed with the European Union Agency for Railways (ERA) on the implementation of the European Union legislation aiming at improving the competitive position of the railway sector
Directorate-General for Environment (DG ENV)
- Example: Cooperation regarding the related General Verification Protocol (GVP) and the new standard ISO 14034 Environmental management — Environmental technology verification (ETV)
Focus on rail safety in Europe
Improving rail safety is the essential precondition for sustainable, competitive rail business and safe transportation in Europe. To achieve this, the European Union Agency for Railways (ERA) contributes, on technical matters, to the implementation of the European Union legislation aiming at improving the competitive position of the railway sector.
An EA/ERA project was conducted and successfully completed in 2017 regarding the assessment of Notified Bodies. But EA is cooperating with ERA on three different activities in the railway sector.
- Directive (EU) 2016/797 on the interoperability of the rail system (IOD) and Regulation (EU) 2016/796 on the European Union Agency for Railways: EA collaborated with ERA in the drafting of the Technical Document on Requirements for Conformity Assessment Bodies (CABs) seeking notification. The main objective was to develop a detailed set of requirements, technical requirements in particular, that Notified Bodies need to improve on and harmonize their general level of performance under Directive 2008/57/EC to increase trust in their work. The assessment scheme developed is divided into two parts: the first containing general references and information on legal requirements for Notified Bodies, the NAB assessment teams, accreditation information, etc., and the second providing sectorial requirements to apply when accrediting CABs for the purpose of notification under the IOD. Click HERE to download the Technical Document on Requirements for Conformity Assessment Bodies (CABs) seeking notification
- Implementing Regulation (EU) No 402/2013 on the common safety method for risk evaluation and assessment
- Regulation (EU) 445/2011 on a system of certification of entities in charge of maintenance for freight wagons: EA supports ERA regarding the implementation of Regulation (EU) 445/2011 Article 10 and related provisions for providing information on accredited bodies.
EU Emission Trading System (ETS)
The EU ETS is a cornerstone of the EU’s policy to fight climate change and one of the key tools for reducing greenhouse gas emissions. The monitoring and reporting of greenhouse gas emissions must thereby be robust, transparent, consistent and accurate for EU ETS to operate effectively.
As a result, in 2015, EA extended its Multilateral Agreement (EA MLA) to the new scope “Greenhouse Gas Validation and Verification” after having signed a specific agreement with the Directorate-General Climate Action of the European Commission in August 2013 for the implementation of accreditation and peer evaluation of EA National Accreditation Bodies (NAB) according to EN ISO 14065 and Commission Regulation (EU) No 600/2012.
To date, 24 EA Members are signatories to the EA MLA for the scope GHG Validation and Verification with 145 accreditations valid at the end of 2017 (Source: EA survey – January 2018).
Moreover, to facilitate collaboration with DG CLIMA, EA has established the EU ETS Network Group, to provide regular input to the updates of current regulations in order to enhance the position of National Accreditation Bodies (NAB) so they are more harmonized and effective in initiating improvements. As an example, EA is involved in the discussions regarding the revision of EU ETS Monitoring and Reporting Regulation (MRR: Commission Regulation (EU) No. 601/2012) and EU ETS Accreditation and Verification Regulation (AVR, Commission Regulation (EU) No. 600/2012).
For further information:
EU Emission Trading System (EU ETS)
See the list of National Accreditation Bodies (NAB) that have successfully undergone or are undergoing peer evaluation by EA for accreditation of verifiers as required by Article 64 of Commission Regulation (EU) No 600/2012, and whose accreditation certificates delivered to accredited verifiers shall be accepted by Member States which shall respect the right of verifiers to carry out verification for their scope of accreditation.
MRV Shipping Regulation
See the list of National Accreditation Bodies (NAB) providing the service for accreditation of Verification Bodies for assessment of monitoring plans and verification of emissions reports according to Regulation (EU) 2015/757 and Delegated Regulation (EU) 2016/2072.
EU Legislations and Projects
Accreditation can operate in various sectors:
- Data Protection & Cybersecurity Act
- Safer and cleaner cars
- Pesticide residues analyses
- Breast Cancer Services
Further details on the “Ongoing developments” page.