Selected aspects of regulation in four member States, early 2010

General legislative framework
Belgium	The federal, three regional, and three community governments legislate in their areas of competence; laws issued by the federal government and decrees issued by regions and communities (called "ordinances" in the case of Brussels-capital region) are on an equal footing; in addition, each government has a sub-structure of secondary regulations, also on an equal footing with each other.
Germany	Federal laws are usually fleshed out in secondary legislation issued by the Länder. Länder issue their own laws and regulation in areas of exclusive Land competence; they may delegate implementation responsibilities to the counties and municipalities: The hierarchical status of legal instruments depends on the enacting body. Municipalities do not have legislative powers per se, but can issue implementing bye-laws on permits and licences.
Sweden	In general, primary legislation (proposed by the government and enacted by parliament) is fleshed out in secondary regulations (ordinances and regulations) by government agencies: Only the parliament and the government have the right, under the Instrument of Government, to issue legal norms; however both the parliament and the government may delegate rulemaking powers to government agencies and local governments.
United Kingdom	Primary legislation, which is contained in acts of parliament, often confers powers on the executive to make legislation, which is either notified to, or approved by, the parliament; the assemblies in Scotland, Wales and Northern Ireland can make laws in their own areas of competence.
Forward planning
Belgium	Each government issues a policy statement agreed by the coalition parties at the beginning of a legislature.
Germany	The coalition agreement adopted by the coalition parties at the beginning of each legislative term sets the general policy framework; the chancellery summarizes ongoing and future ministerial projects in a document that is regularly updated.
Sweden	Based on the coalition agreement at the start of each political term, the prime minister's office submits a list of upcoming bill proposals twice a year to the parliament.
United Kingdom	The annual Queen’s speech on the opening of the parliament sets out the main lines of the legislative programme for the coming year. Major policy proposals are presented in white papers by government ministries. Forward planning procedures for secondary regulations are much less developed and there is no systematic coordination.
Rulemaking procedures
Belgium	General procedures for making new federal regulations are laid down in several circulars related to the operation of the Council of Ministers.
Germany	The constitution and the Administrative Procedures Act set out a framework of general administrative procedure requirements; more elaborate standardized procedures to create new legislation at the federal level are set out in the Joint Rules of Procedure of the federal ministries, which are binding.
Sweden	The Instruments of Government sets out consultation procedures for rulemaking.
United Kingdom	There is no general administrative procedure law; instead, the UK relies on a range of codes and guidance covering different policy fields and issued by different government entities.
Public consultation
Belgium	Stakeholders are generally consulted through a dense, highly structured and extensive network of advisory boards comprising representatives of target groups related to various policy/regulatory issues. Other forms of consultation, including more open "notice and comment" procedures using the Internet to reach out directly to citizens, are emerging alongside the traditional approach.
Germany	Public consultation by the federal government is formally regulated by the Joint Rules of Procedure, which specifies that ministries must consult early and extensively with a range of stakeholders. In practice, individual ministries have significant latitude on such issues as feedback, timing, publication of comments, and selection of consultation partners. Informal pre-consultation rounds (with the Länder, municipalities and associations) are the norm at an early stage in the process before a bill is drafted. Although e-consultation is an important and steadily emerging feature, the federal government has nonetheless not yet established a single web portal for all current and previous consultation on federal initiatives.
Sweden	Public consultation by the government with parties affected by draft legislation is in principle mandatory. A key element of the consultation process is the Committee of Inquiry: before the government makes legislative proposals, a Committee of Inquiry writes a report that is referred to relevant bodies for consideration; reports are published. Beyond the Committee of Inquiry system, which covers major legislation, there is a general requirement to consult. There are no explicit or shared guidelines on how to carry out this consultation. Ministries and agencies may define their own approach, including direct consultation of the public.
Table III.8 (cont'd)
Public consultation
United Kingdom	The Code of Practice on Consultation, revised in 2008, promotes an open consultations approach, but the recent review of the Code of Practice on Consultation showed that there was concern at the way consultations are carried out in practice. The Code applies to all central government departments and agencies that have a close relationship with a parent department. All departments put their consultation exercises on a departmental web page; work is under way to develop a comprehensive online tool providing access to all central government consultations.
Access to regulations
Belgium	Regulations are accessible through different official publications and websites; regulations at the federal, regional, and community levels are published in the official journal, which is available online; in addition, regulations are compiled in a website, with consolidated versions and search facilities.
Germany	Once a law or an ordinance is enacted, it is promulgated in the federal official journal. A publicly available database of federal administrative regulations has been in place since 2006.
Sweden	There is an obligation on the government to publish acts and ordinances, including amendments, in the Swedish Code of Statutes; there is also an online database containing a directory of all laws, ordinances and government agency regulations. The government also publishes bi-annually general information on important new laws that will enter into force in the coming six months.
United Kingdom	Several databases of information on regulations are available, but none is comprehensive; the Ministry of Justice is extending the statute law database which will cover primary and secondary regulations in current form, i.e. including subsequent amendments
Ex-ante impact assessment
Belgium	Ex ante impact assessment is a relatively new policy in Belgium, and still a "work in progress". With the exception of the process in Flanders, impact assessment remains mostly focused on administrative burdens, although there have been recent efforts to extend its scope.
Germany	Impact assessment is backed up by a comprehensive handbook issued by the Interior ministry in 2006. Key impacts are covered including environmental, economic and social. The process is applied to primary legislation, and partially covers secondary regulations. The approach is comprehensive on paper, but in practice impact assessment appears to have a limited impact on decision-making.
Sweden	A new policy seeks to promote a more systematic and more coherent approach going beyond impacts on small firms, and a strengthened institutional framework. The emphasis remains firmly on the economic and business aspects. The centrepiece of the revised approach is a new Regulatory Impact Assessment Ordinance for the government agencies, which entered into force in January 2008. The ordinance sets specific requirements for impact assessment.
United Kingdom	The government has recently updated its policy on ex ante impact assessment; the new process is designed to promote greater transparency and sharpen the approach via enhanced quantification and a process to promote "early stage" consideration of costs and benefits before a policy is too advanced, the overall objective being to ensure that the benefits of new regulations justify the burdens. Wide-ranging institutional and methodological support is in place.
Enforcement
Belgium	Inspections and enforcement follow the lines of Belgium's division of competences between governments. For areas of federal competence, inspections are under the responsibility of units of relevant ministries, or administrative agencies; the same structure applies to regions and communities with respect to their competences. There is a significant enforcement role at the local level of government. Risk analysis is well established in inspection methodologies.
Germany	Most legislation adopted at the federal level is implemented and enforced by the Länder, which rely extensively on the districts, counties, and municipalities to execute state and even federal legislation. Risk based approaches to enforcement are not explicitly practiced.
Sweden	The current approach to enforcement is complex and widely acknowledged to be in need of reform. Enforcement responsibilities are spread across a range of bodies, and regulated in different ways through more than 230 laws. The government has started to take steps to rationalise and clarify enforcement responsibilities. A risk based approach is not yet used to a large extent.
United Kingdom	Responsibilities for enforcement are divided between national regulatory agencies and local authorities. There has been a reappraisal of the approach to enforcement, resulting in the adoption of new statutes (Regulatory Enforcement and Sanctions Act, enacted in July 2008, and the Regulators Compliance Code, which came into force in April 2008). There has been steady progress towards the adoption of common principles of regulatory enforcement based on risk assessment.
Regulatory streamlining
Belgium	Procedures for ex post review of regulations are still under development. Legislation only rarely provides for ex post review. Sunset clauses are not commonly used. At the federal level, one of the "Twelve Strategic Works" outlined in the policy note of the federal government provided for the introduction of ex post evaluation of existing laws. This led to the establishment of the Parliamentary Committee for Legislative Monitoring in 2007. Regional governments are also trying to develop ex post review mechanisms.
Table III.8 (cont'd)
Regulatory streamlining
Germany	The federal government has passed several laws to repeal redundant regulations, and a Simplification Act to clean up the stock of environmental regulations. However, the German system does not encourage sunset clauses or other devices that would trigger reviews of individual regulations.
Sweden	Sweden is active in the use of different processes aimed directly at regulatory streamlining. The Action Plan for Better Regulation, set up in 2006, is updated annually and covers a broad range of regulatory simplification measures.
United Kingdom	Although there are a number of useful initiatives, there is no systematic effort to consolidate or simplify the regulatory stock. A new impact assessment form requires officials to commit to a date when they will review the actual costs and benefits of any new proposal, and establish whether the policy has achieved the desired effects. This post implementation review should typically occur within three years of implementation, depending on the nature of the policy.

Source: WTO Secretariat, based on OECD (2010), Better Regulation in Europe (various issues), Paris.

 

83. According to the Commission, the EU notifies draft measures to the WTO once a complete text of the measure is available, but at a stage when comments can be taken into account. Some WTO Members consider that public consultations on EU regulatory proposals could be enhanced.[93] For example, one Member noted that, by the time the EU issues public notices of proposed regulations, deliberations among EU member States have progressed too far to allow for the meaningful consideration of trading partners' views.

84. Proposed technical regulations and conformity assessment procedures may be subject to impact assessment by the Commission. Pursuant to the EU's "Better Regulation Policy", all "major" policy initiatives and legislative proposals "with potential significant economic, social, and environmental impacts" must undergo impact assessment. Under the Commission's guidelines on impact assessment, revised in 2009, assessment should include analyses of the effects of trade and investment policies on foreign and domestic businesses and consumers, and of particular policies on the EU's WTO obligations.[94]

85. The requirements relating to technical regulations and conformity assessment procedures are listed by sector in the Export Helpdesk website of the Commission.[95] In addition, an overview of EU legislation relating to various product areas is available on the website of the Commission's Directorate-General for Enterprise and Industry.[96]

86. Under the "new approach" to technical harmonization launched in the mid-1980s, technical regulations adopted at the EU level contain "essential requirements" expressed in terms of performance-based indicators or objectives, leaving manufacturers free to determine the technical characteristics to comply. Essential requirements define the results to be attained, or the hazards to be dealt with, without specifying any particular technical solution. Technical solutions to meet essential requirements are set out in harmonized standards developed by the European Standardization Organizations based on a mandate from the Commission. Compliance with these standards confers a presumption of conformity with the essential requirements covered by the standards. Technical regulations adopted prior to the introduction of the new approach usually establish detailed specific technical requirements. Motor vehicles are entirely subject to the old approach. New-approach regulations cover a wide variety of products, including electrical and electronic products, pressure equipment and gas appliances, toys, machinery, medical devices, radio and telecom equipment, elevators, personal protective equipment, equipment for use in explosive atmospheres, and recreational craft. The Commission does not have data on the market shares of products subject to old and new approach legislation. According to the Commission, some sectors, for example chemicals, are subject to both types of approaches.

87. In the context of its previous Review, the EU stated that EU legislation relies on supplier's declaration of conformity for a "major part" of goods marketed in the EU.[97] Some of the goods subject to supplier's declaration of conformity are electrical and electronic products, energy-related products subject to eco-design requirements, radio and telecom equipment, most machinery, toys, refrigeration appliances, and some categories of pressure equipment, personal protective equipment, recreational craft, and medical devices. In addition, supplier's declaration of conformity is used for goods that, in the absence of more specific safety legislation at the EU level, are subject to the General Product Safety Directive.[98] These goods include childcare goods, textiles, and several other consumer goods. Third-party conformity assessment conducted by "notified bodies" is used for products deemed high-risk. Notified bodies are certification, inspection, and testing bodies designated by member States to perform specific conformity assessment activities mandated under EU product legislation. The designation of notified bodies by member States involves a technical assessment, typically based on accreditation, and a political decision whereby member States take responsibility for the operation and supervision of the notified body.[99] Conformity assessment bodies that are not established in the EU cannot qualify as notified bodies.

88. In July 2008, the European Parliament and the Council adopted the New Legislative Framework, a package of measures that seeks to remove "the remaining obstacles to free circulation of products" within the EU. The New Legislative Framework consists of Decision No. 768/2008 and Regulation 765/2008.[100] Decision No. 768/2008 contains common principles and reference provisions for the future development of (or amendment of existing) harmonizing legislation. It sets out a menu of conformity assessment procedures, and the criteria to choose among them, including the nature of the risk associated with the product, the need to avoid imposing too burdensome conformity assessment requirements in relation to the risks, and the appropriateness of the conformity assessment procedure to the type of product, and to the type and degree of risk. According to the Commission, the Decision transposes into EU legislation the toolbox of conformity assessment procedures elaborated by the ISO Conformity Assessment Committee. In developing new or amending existing legislation, EU legislators must justify any departure from the common principles and reference provisions contained in Decision 768/2008. During 2010, the Commission held public consultations on its proposal to align ten existing new-approach directives to the new provisions of Decision No. 768/2008.[101]

89. Pursuant to the New Legislative Framework, accreditation should be the preferred method for determining the technical competence of a particular certification, inspection, or testing body under EU product legislation that requires third-party conformity assessment. From January 2010, the EU applies a new common framework on accreditation, set out in Regulation 765/2008. Accreditation was previously governed by national legislation. According to the Commission, in the absence of a common legal basis, member States had been using "different approaches to accreditation, applying differing systems with uneven rigour".[102] The objectives of the new accreditation framework are to: create confidence in the quality of conformity assessment bodies and their certificates; ensure common and transparent rules for the assessment of the competence and monitoring of conformity assessment bodies; and stabilize the accreditation system in the EU.

90. Under the new framework, member States must appoint a single national accreditation body, which must operate accreditation under the principles set out in Regulation No. 765/2008. For example, national accreditation bodies cannot be involved in conformity assessment, operate on a for-profit basis, or compete with other accreditation bodies in the member State where they are established, or elsewhere in the EU. The new framework recognizes the European Cooperation for Accreditation (EA), as the official accreditation "infrastructure", responsible for managing peer evaluations of national accreditation bodies' conformity to the relevant legal requirements. All national accreditation bodies must be members of the EA, and regularly submit to peer evaluation.

91. National accreditation bodies must recognize the equivalence of the services of other national accreditation bodies that have successfully passed the peer review. Member States cannot refuse certificates or test reports issued by a conformity assessment body accredited by another member State's national accreditation body.[103] Regulation No. 765/2008 does not contain provisions relating to the recognition of non-EU accreditation bodies, or the acceptance of certification and test reports issued by such bodies.

92. Under EA policy, the relationship with accreditation bodies from countries outside EFTA or the "European neighbourhood" should be managed through the International Accreditation Forum (IAF) Multilateral Recognition Agreement (MLA) and the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement (MRA).[104] According to the policy, "in certain exceptional cases, EA could offer to ABS [accreditation bodies] from some of these countries the possibility of signing a Cooperation Agreement", subject to conditions, including the fulfilment by the foreign accreditation body of "all the specific requirements established by EA for its members, pursuant to Regulation (EC) 765/2008". Regarding countries from the European neighbourhood, the EU has concluded an agreement on conformity assessment and acceptance of industrial products (ACAA) with Israel in the field of pharmaceuticals. This agreement is not yet in force (March 2011). In addition, ACAA negotiations are ongoing with Croatia and the Former Yugoslav Republic of Macedonia. Preparations for ACAA negotiations are under way in additional sectors with Israel, and with Algeria, Egypt, Jordan, Lebanon, Morocco, the Palestinian Authority, Tunisia, and Ukraine. ACAAs are a specific type of mutual recognition agreement based on the alignment with the EU of relevant product legislation and infrastructure.

93. Some WTO Members have expressed concerns about the possible impact of the new EU accreditation framework on member States' recognition of non-EU accreditation bodies under the IAF MLA, and the ILAC MRA (see Table III.7 above). In response, the EU indicates that the common accreditation framework is a tool to support the EU's internal regulatory policy based on the existing international accreditation framework. In addition, the EU notes that the common framework is not intended to "change or undermine" international cooperation agreements between accreditation bodies; and does not "affect or force changes in the accreditation practices in third countries".

94. In addition to a common accreditation framework, Regulation No. 765/2008 sets out common principles for market surveillance. According to the Commission, a majority of member States have made legal and administrative changes to meet these requirements.[105] Under the Regulation, customs authorities must carry out "appropriate checks on the characteristics of products on an adequate scale" before those products can be marketed in the EU.[106]

95. In principle, EU and imported goods that are not covered by EU harmonizing legislation and have been lawfully placed on the market of a member State can be marketed in another member State, even if they do not comply with the technical regulations of the member State of destination. The only exceptions to this principle are restrictions introduced for reasons specified in Article 36 TFEU, or for other overriding reasons of public interest that are proportionate to the aim pursued. According to the Commission, the most common justification for restrictions on the free movement of goods is related to the protection of health and life of humans, animals, and plants. As recognized by the European Parliament and the Council, "many problems still exist as regards the correct application of the [mutual recognition] principle".[107]

96. In July 2008, the European Parliament and the Council adopted Regulation No. 764/2008 "to minimise the possibility of technical rules' creating unlawful obstacles to the free movement of goods between Member States".[108] Under the procedures, which apply from May 2009, member States that use technical regulations to restrict market access for products lawfully marketed in another member State must justify their position with technical or scientific evidence, and must grant economic operators affected by the restriction an opportunity to provide comments. The new procedures operate alongside the notification procedure under Directive 98/34/EC, through which the Commission and member States have monitored member States' proposals to introduce technical regulations or conformity assessment procedures since the early 1980s.[109] Between the entry into force of Regulation No. 764/2008 and December 2010, the Commission received 1,114 notifications from 7 member States denying within their territory the marketing of non-harmonized products lawfully marketed in other member States. The notifications cover articles of precious metal, food additives, foodstuffs, fertilizers, and medicinal products.

97. Although compliance with "harmonized European standards" is voluntary, in practice there is a strong incentive for EU and foreign manufacturers to meet the standards referred to in new-approach technical regulations. This is because under the new approach to product regulation, only products that conform to "harmonized European standards" benefit from the presumption of conformity with the relevant legislative requirements. Harmonized European standards are developed by the European Standards Organizations, that is, the European Committee for Standardization, the European Committee for Electrotechnical Standardization, and the European Telecommunications Standards Institute, upon request from the European Commission. European Standards Organizations have accepted the WTO Code of Good Practice. In addition, all member States have notified the acceptance of the Code by one or more of their national standards organizations.

(ix) Sanitary and phytosanitary standards (SPS)

98. The European Union and each of its member States have notified enquiry points under the SPS Agreement.[110] The Directorate General for Health and Consumers of the European Commission is the EU notification authority.[111] Member States are members of the Codex Alimentarius Commission, the World Organization for Animal Health (OIE), and the International Plant Protection Convention (IPPC). The EU is a member of Codex and the IPPC.

99. The EU notified 56 regular and 3 emergency SPS measures to the WTO between October 2008 and mid-January 2011. The EU considers that, of the 35 notified measures for which there was a relevant international standard, 27 conformed to that international standard. Apart from the emergency notifications, almost 60% of notifications specified the multilaterally recommended 60-day period for public comment; for the rest, the EU considered that a comment period was not applicable, or the period between the publication of the notification and the adoption of the measure was less than 60 days. The EU identified 15 notified measures as "trade facilitating". In addition, during the period under review, the EU submitted a large number of addenda, providing additional information on previously notified SPS measures.

100. The Netherlands made the only notification from a member State during the period under review.[112] The notification covers an emergency measure affecting imports of ornamental plants from China.

101. Since the last Review of the EU, WTO Members have discussed concerns in the SPS Committee regarding several EU measures (Table III.9). Of the ten trade concerns raised, two have been resolved or partially resolved, and one was followed by formal dispute settlement, with a panel established in November 2009.[113] In October 2010 the EU submitted a document to the SPS Committee identifying 14 specific trade concerns that it had raised, and that it considered resolved.[114]

Table III.9

Specific trade concerns over EU SPS measures, October 2008 to January 2011^a

	Relevant source document^b	Raised by	Date first raised	Solution
Maximum residue levels of pesticides	G/SPS/R/61	India	October 2010	Not reported
Regulation 1099/2009 on the humane treatment of animals	G/SPS/R/59	India	June 2010	Not reported
Artificial colour warning labels	G/SPS/R/59	United States	March 2010	Not reported
Risks arising from carambola fruit fly in French Guyana	G/SPS/R/58	Brazil	March 2010	Not reported
Measures related to wood packaging material	G/SPS/R/58	Canada	November 2000	Resolved
Regulation on novel foods	G/SPS/R/56	Colombia, Ecuador, Peru	March 2006	Not reported
Greece's inspection and testing procedures for imported cereals	G/SPS/R/55	Canada	March 2005	Not reported
Table III.9 (cont'd)
Import restrictions on cooked poultry	G/SPS/R/53	China	October 2007	Partially resolved
Maximum residue levels for pesticides in cacao	G/SPS/R/53	Ecuador	October 2008	Not reported
Restrictions on U.S. poultry exports	G/SPS/R/51	United States	October 2006	Under dispute settlement

a Covers concerns raised, addressed, or resolved between mid 2008 and October 2010.

b Only the most recent source document is cited.

Source: WTO Secretariat.

 

102. According to the Commission, SPS measures are adopted mostly at EU level, although member States may also adopt SPS measures. The main EU legislation on SPS is contained in Regulation No. 178/2002, known as the General Food Law; Regulations No. 852/2004, 853/2004, and 854/2004 on food hygiene; Regulation No. 882/2004 on official controls; and Council Directive 2000/29/EC on plant health.[115]

103. The Commission's Animal Health Strategy for the period 2007-13 aims to replace "the existing series of linked and interrelated policy actions by a... single clear regulatory framework converging as far as possible with the OIE/Codex recommendations/standards and guidelines".[116] The deadline for the preparation of a legislative proposal on animal health is March 2012. In addition, the Commission intends to adopt, in a package with the draft animal health law, legislative proposals for: a review of the regulation on official controls for feed and food; plant health legislation; and legislation on seeds and propagation materials.

104. The adoption of EU basic acts on SPS require the assent of both the European Parliament and the Council under the ordinary legislative procedure (see Chapter II(1)). SPS measures at the EU level are usually established on the basis of implementing powers conferred on the Commission by means of an EU basic act. Thus, their formulation and adoption has been subject to the "comitology" procedure. The main regulatory committees involved in the development of SPS measures are the Standing Committee on the Food Chain and Animal Health and the Standing Committee on Plant Health. Following the entry into force of the Lisbon Treaty in December 2009, new rules govern the Commission's exercise of implementing powers (see Chapter II(1)). Furthermore, under the Lisbon Treaty, SPS measures may also be established on the basis of powers conferred on the Commission to adopt "delegated acts".

105. The General Food Law set out the general principles governing food and feed at EU and national levels. Measures adopted under the Law must be based on risk analysis "except where this is not appropriate to the circumstances or the nature of the measure".[117] According to the Commission, no measures have been adopted under this exception since the last Review of the EU. Risk management must take into account the opinions of the European Food Safety Authority, an independent institution that provides scientific advice on food safety issues.

106. The General Food Law permits the establishment of "provisional" measures if "the possibility of harmful effects on health is identified but scientific uncertainty persists".[118] These measures must be "proportionate and no more trade restrictive of trade than is required to achieve the high level of health protection" in the EU, and must be reviewed "within a reasonable period of time".

107. Measures adopted under the General Food Law must take into consideration international standards, "except where such standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives of food law or where there is a scientific justification, or where they would result in a different level of protection from the one determined as appropriate in the Community". Regarding animal health and food of animal origin, the Commission indicates that EU legislation is largely based on OIE/Codex recommendations, standards, and guidelines.[119] According to the Commission, there are areas where the EU could increase its convergence with these standards, including disease status, imports, quality and evaluation of veterinary services, laboratory testing, animal nutrition, and vaccination. Regarding measures in the field of plant health and products of non-animal origin, the Commission notes that the EU always follows the relevant international standards.

108. Imported food must comply with the relevant requirements of EU food law and animal health law; conditions recognized by the EU to be at least equivalent to these requirements; or the requirements contained in specific agreements. The EU has SPS agreements with Andorra, Canada, Chile, EFTA, Faroe Islands, Liechtenstein, Mexico, New Zealand, San Marino, Switzerland, and the United States. These agreements are available online.[120]

109. Imports of live animals and products of animal origin are prohibited unless they are from a country or region that has received prior approval, and thus appears on the relevant "third country list" managed by the Commission. The term products of animal origin covers food that has been derived from animals or comes from animals, whether processed (e.g. ham, marinated fish, egg powder, and gelatine) or not (e.g., fresh meat, fishery products, raw milk, eggs, and honey).[121] It also covers products not intended for human consumption, whether processed (e.g. pet food) or not (e.g. raw material for pharmaceutical use, wool, hides, and skins).

110. Requests for first-time imports of live animals and products of animal origin must be submitted to the Commission by the competent national authority of the exporting country. In general, the approval process involves an audit, including an on-site visit, by the Commission's inspection service, the Food and Veterinary Office (FVO). The objective of the inspection is to evaluate whether the animal and public health situation, official services, legal provisions, control systems, and production standards meet EU requirements. The Commission indicates that it does not charge a fee for its audits and pays for the expenses of the audit team.

111. If the outcome of the inspection is satisfactory, the Commission prepares draft legislation to include the country in question in the lists regarding animal and public health. The Commission adopts the draft legislation provided that the Standing Committee on the Food Chain and Animal Health agrees. Approvals may cover all or part of a country, reflecting its animal and public health status and the type of animal or product of animal origin for which approval is sought. Applicant countries must be OIE members, have systems in place for the rapid detection, reporting, and confirmation of OIE listed diseases, and fulfil other legislative requirements. The Commission has published guidance on these requirements.[122]

112. In addition to being entered in the relevant list, countries seeking to export animals and products of animal origin to the EU must obtain approval for their residues monitoring programme. Individual slaughterhouses, processing plants, fishing vessels, and other establishments must also be listed for export to the EU on the basis of a proposal from the exporting country. In general, only products of animal origin from establishments that appear on the relevant list can export to the EU. For food, these approvals also involve the adoption of legislation by the Commission. The Commission has published guidance on the criteria for these approvals.[123] Imports of meat are also subject to certification on the protection of animals at the time of slaughter or killing.[124] There are no statutory limitations regarding the duration of the process to approve first-time imports of live animals and products of animal origin.

113. Unlike for animals and products of animal origin, first-time imports of plants and their products require pre-approval. The same principle applies on food of non-animal origin, which includes fruits, vegetables, cereals, drinks, spices, condiments, and food of mineral origin. All food must comply with the general requirements on food hygiene in Regulation No. 852/2004, and, depending on the product, on contaminants, pesticide residue levels, food additives, food irradiation, novel foods, and radioactivity. There are also product-specific requirements for quick frozen foodstuffs, foodstuffs for particular nutritional purposes, and genetically modified organisms. Certain plants and plant product must comply with phytosanitary requirements.

114. Control procedures on imports of animals and products of animal origin are largely harmonized across the EU.[125] Imports of these products must be accompanied by health certification attesting to the fulfilment of EU import conditions.[126] They must undergo official controls at an EU approved border inspection post, and may be subject to additional controls at their country of destination. The list of approved "border inspection posts" is reviewed three or four times per year; there are around 300 within the EU. The official controls in the border inspection posts involve documentary, identity, and physical checks. The frequency of physical checks can be reduced for products of animal origin subject to EU harmonized requirements, taking into consideration the risk profile of the product in question.[127] Live animal imports must be notified to the border inspection post at least 24 hours before arrival, while imports of products of animal origin must be notified before arrival. The first part of the Common Veterinary Entry Document is used for this notification; the notification can be carried out electronically through the Trade Control and Expert System, known as TRACES. Consignments of live animals and products of animal origin must also be accompanied by the model health certificate set out in EU legislation for the relevant species or product. In the absence of an EU model health certificate for a particular species or product, member States may establish their own import requirements.

115. Certain products of animal origin are subject to "special import conditions", which consist mostly of 100% testing of each import consignment or pre-export testing and certification. These measures affect nine WTO Members and involve fishery products, horse and rabbit meat, poultry, eggs and egg products, honey, and milk powder (July 2010).[128]

116. National authorities must organize regular official controls for imports of feed and food of non-animal origin. Control activities at national level must take place at an appropriate place, which may be the border, point of release for free circulation, or retail outlets.[129] In general, feed and food of non-animal origin may enter the EU without certification by the exporting country or pre-arrival notification. Consignments of certain imports of feed and food of non-animal origin specified in Annex I to Regulation No. 669/2009 must be notified prior to arrival, and must enter the EU through designated points of entry, where they are subject to reinforced controls.[130] These include documentary checks on all consignments, and identity and physical checks, including laboratory analysis, at the frequency established by the Annex. Annex I is subject to quarterly review.

117. Plants and plant products listed in Council Directive 2000/29/EC (Annex V, Part B) must be accompanied by a phytosanitary certificate issued by the competent authority of the exporting country, and are subject to border controls, including physical inspection.[131] The frequency of controls may be reduced for products from specific countries, based on risk profiling.[132] There are 51 products from specific countries subject to reduced inspections.[133] Unless determined by member States on an exceptional basis for particular commodities, imports of plants and plant products are not restricted to specific border posts.

118. The Rapid Alert System for Food and Feed (RASFF) is a network managed by the Commission that allows food and feed authorities of member States to exchange information about measures taken in response to serious risks detected in relation to food and feed. The legal basis for RASFF is the General Food Law, which sets out the criteria for notification to RASFF.[134] For example, members of RASFF are required to notify rejections of food or feed at the border if the consignment is rejected because of a risk to human or animal health. Border rejections represent just under half of the original notifications to RASFF.[135] In 2009, there were about twice as many border rejection notifications regarding food of non-animal origin than animal origin. The main category of food of non-animal origin notified in border rejections is “nuts, nut products and seeds”, while fish is the main category of food of animal origin.

119. Under Regulation No. 882/2004, the Commission may recognize specified pre-export checks that a non-EU member State carries out on feed and food.[136] The Commission recognizes pre-export controls carried out by the United States on peanuts and derived products with respect to aflatoxins.[137] The EU is discussing with Canada the possibility of recognizing Canada's pre-export checks of wheat and certain derived products with respect to ochratoxin A.

120. The use of genetically modified organisms (GMOs) is regulated at EU level on the basis of Regulation No. 1829/2003 on genetically modified food and feed, Directive 2001/18/EC on the deliberate release of GMOs into the environment, and Regulation 1830/2003 on the traceability and labelling of GMOs, and food and feed produced from GMOs.[138] Member States may not legislate with respect to the cultivation of GMOs, only to their use. In July 2010, the European Commission adopted a proposed regulation to amend Directive 2001/18/EC to allow member States to restrict or prohibit the cultivation in all or part of their territories of GMOs authorized at the EU level. Under the proposed regulation, member States may adopt measures with respect to the cultivation of GMOs in their territories, but not with respect to the import into the EU of authorized GM seeds and plant propagating material, and the products of their harvest. Prohibitions or restrictions would be based on grounds other than those covered by the environmental and health risk assessment under the existing EU authorization system for GMOs. According to this system, the level of protection of human and animal health and of the environment chosen in the EU may not be revised by a member State.

121. Under the proposed regulation, member States must notify measures they intend to adopt, and the reasons for adopting them, to the Commission and to the other member States one month prior to their adoption. The proposed legislation does not change the authorization procedure for GMOs. The Commission's legislative proposal is subject to the procedure on co-decision with the European Parliament and the Council.

122. According to the Commission, the new approach is necessary "to achieve the right balance between maintaining the EU system of authorisations based on scientific assessment of health and environmental risks and the need to grant freedom to Member States to address specific national, regional or local issues raised by the cultivation of GMOs".[139] Several member States have prohibited or restricted cultivation of GMOs authorized at the EU level. For example, Austria, France, Germany, Hungary, and Lithuania have prohibited maize MON 810; Austria has prohibited maize T 25; and Austria, Hungary, and Luxembourg have prohibited Amflora potato. According to the scientific opinion of the European Food Safety Agency, "these measures were not based on new or additional scientific information since the authorizations were granted and therefore such measures were not justified from a legal point of view."[140] A judgement issued by the Court of Justice of the EU in July 2009 considered that legislation adopted by Poland to prohibit the marketing of GM seeds was contrary to EU law.[141]

(2) Measures Directly Affecting Exports

(i) Registration and documentation

123. Persons established in the EU who are involved in activities covered by customs legislation must be in possession of a national number that is valid as an Economic Operator Registration and Identification (EORI) number (see section (1)(i)).

124. Since July 2009, export declarations must be lodged electronically at the customs office of export, i.e., the customs office designated by the customs authorities for the completion of the formalities (for goods destined to leave the customs territory of the Community).[142] In principle, export declarations for containerized maritime cargo must be lodged at least 24 hours before the cargo is loaded on the outbound vessel; export declarations for other cargo must be lodged before the goods leave the EU.[143] The EU Customs Code Implementing Regulation specifies certain exceptions.[144]

125. Export declarations must contain the security data specified in Annex 30A of the EU Customs Code Implementing Regulation. Security data are not required for exports to Liechtenstein, Norway, and Switzerland. Exports from authorized economic operators are subject to reduced security data requirements (see section (1)(i)).

(ii) Export taxes and fees

126. The EU does not apply taxes on exports.

(iii) Restrictions and controls

127. There have been no major changes, during the review period, in the EU legal framework governing export restrictions and controls. EU member States maintain quantitative restrictions and controls on exports for foreign policy and security reasons.[145] Arms exports are controlled at the member State level. In assessing applications to export arms listed in the EU Common Military List, member States have agreed to follow the EU Code of Conduct on Arms Exports.[146] The Common Military List was updated in March 2008.[147]

128. Exports of "dual-use" items are controlled at the EU level. The EU's dual-use export control system, set out in Regulation No. 428/2009, defines dual-use items as "items, including software and technology, which can be used for both civil and military purposes, and shall include all goods which can be used for both non-explosive uses and assisting in any way in the manufacture of nuclear weapons or other nuclear explosive devices".[148] The list of controlled dual-use items is contained in Annex I of the Regulation. Member States may impose export controls on unlisted dual-use items under certain conditions specified in the Regulation.[149]

129. Exports of most controlled items to Australia, Canada, Japan, New Zealand, Norway, Switzerland, and the United States are authorized under the Community General Export Authorizations. The specific conditions for exporting under the Authorizations are specified in Annex II of Regulation No. 428/2009; member States may impose certain additional administrative requirements.

130. All other exports controlled under Regulation No. 428/2009 are subject to authorization granted by the member State where the exporter is established. There are national general, global, or individual authorizations, all of which are valid throughout the EU. France, Germany, Greece, Italy, the Netherlands, Sweden, and the United Kingdom have national general authorizations, which must be granted in accordance with the conditions set out in Article 9(4) of the Regulation. Individual and global authorizations are granted to one exporter, and cover either one end user (individual) or several countries and end users (global). In assessing applications for individual or global authorizations, member States must take into consideration the criteria specified in the Regulation.[150]

131. The European Commission indicates that "there is a lack of transparency across Member States regarding both the scope and conditions of use of national general export authorisations and the list of exporters denied access to national general export authorisations".[151] According to the Commission, "this leads to regulatory treatment of certain exports that benefits businesses established in one Member State at least partly at the expense of businesses established in and national security interests of other Member States, and is not in the best interests of the Community as a whole".

132. The European Commission proposes creating new Community General Export Authorizations "to simplify the current legal system, enhance the EU industry's competitiveness and establish a level playing field for all EU exporters when they export certain items to certain destinations".[152] The proposal is under discussion in the Council and the European Parliament. In addition, as part of its blueprint for EU trade policy, the Commission announced in November 2010 that it would adopt a Green Paper "seeking to improve [the EU's] export control system".[153]

(iv) Official support and related fiscal measures

133. The EU provides export subsidies to eligible exporters of certain agricultural products (Chapter IV(1)).

134. In June 2010, a WTO panel issued its report on a complaint by the United States against certain EU measures affecting trade in large civil aircraft.[154] Among the panel's findings was that certain instances of financing by Germany, Spain, and the United Kingdom for the design and development of the A380 aircraft constitute prohibited export subsidies. The EU has appealed the panel's report.[155]

135. Under the EU Customs Code's drawback system, importers can claim repayment of import duties paid on imported goods if they export such goods in the form of "compensating products", that is, products resulting from processing operations.[156] In addition, the Customs Code establishes a suspension system whereby imported goods intended for export in the form of compensating products are not subject to import duties.[157] Once in force, the Modernized Customs Code will eliminate the drawback system. The Commission indicates that there are no data on the value of repayments under the drawback system. In addition, the Commission notes that drawback has not played an important role in the EU.

(v) Finance, insurance, guarantees, and promotion

136. Official export credits are subject to EU rules. The Directive on medium- and long-term export credit insurance establishes principles for official insurance and guarantee arrangements, premiums, and cover policies.[158] Export credits are granted at the member State level through official export credit agencies.

137. Following the onset of the financial crisis in 2008, the European Commission simplified the "escape clause" for short-term export insurance.[159] Under the escape clause, member States may, subject to authorization from the Commission, offer export credit insurance cover for "marketable risks", provided that the cover is temporarily unavailable in the private market.[160] Marketable risks are defined as commercial and political risks on public and non-public debtors established in the EU and eight other OECD countries, with a maximum risk period of less than two years. Member States must notify the Commission of their intention to use the escape clause.

138. Under the new simplified procedures, member States invoking the escape clause must provide evidence of the lack of cover for short-term export credit from a large, well-known international private export credit insurer, and a national credit insurer. Alternatively, they must demonstrate that insurers refused to cover specific operations of at least four well-established exporters in its territory. Between mid-December 2008 and October 2010, the European Commission authorized 13 simplified export-credit schemes (Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Latvia, Lithuania, Luxembourg, the Netherlands, Slovenia, and Sweden).[161]

139. In January 2011, the Commission issued a Communication extending the procedural simplification on short-term export credit insurance until end 2011.[162] The Commission notes that "companies still find it difficult to find coverage from private insurers in many sectors and many Member States". In addition, the Commission decided in December 2010 to extend the application of the underlying legal framework on short-term export-credit insurance (the 1997 Communication) until end 2012.[163]

140. The EU provides assistance to promote its agricultural products and food outside the EU (Chapter IV(1)). In addition, export promotion schemes are in place at the national or sub-national levels.

(3) Measures Affecting Production and Trade

(i) Business framework and foreign investment regime

141. Legal and administrative barriers to entrepreneurship in the EU are below the OECD average. Among EU member States, barriers to entrepreneurship are highest in Poland and Greece, and lowest in the United Kingdom, the Netherlands, and Sweden.[164]

142. Corporate income is taxed in every member State, but the rates and the rules for determining the tax base differ substantially. Unlike indirect taxes, EU law does not specifically require harmonization of direct taxes. Corporate income tax rates in the EU average 23.2%.[165] The top statutory tax rate on corporate income ranges from 10% in Bulgaria and Cyprus to 35% in Malta.

143. The Treaty on the Functioning of the EU prohibits restrictions on capital movements among EU member States, and between EU and non-EU members.[166] Restrictions on direct investment from non-EU members that were in place in December 1993 (December 1999 for Bulgaria, Estonia, and Hungary) are exempt from this prohibition.[167] Also exempt are restrictions "justified on grounds of public policy or public security", and those taken "to prevent infringement of national law and regulations, in particular in the field of taxation and the prudential supervision of financial institutions, or to lay down procedures for the declaration of capital movements for purposes of administrative or statistical information".[168]

144. Following the entry into force of the Lisbon Treaty in December 2009, the adoption of measures on direct investment between EU and non-EU members requires the assent of the Council and the European Parliament, in accordance with the ordinary legislative procedure (Chapter II(1)). However, under EU rules on capital movements, if the measure is "a step backwards in Union law as regards the liberalisation of the movement of capital to or from third countries", it must be adopted by the Council unanimously, in consultation with the European Parliament.[169] The Commission notes that no such measures have been adopted since the last Review of the EU. In exceptional circumstances, the Council may adopt temporary safeguard measures restricting capital movements with non-EU member States subject to the conditions set out in Article 66 of the Treaty on the Functioning of the EU.

145. The Treaty on the Functioning of the EU prohibits measures that restrict the "freedom of establishment" of EU nationals in the territory of another member State. This means that companies or firms formed in accordance with the law of a member State, and having their registered office, central administration, or principal place of business in the EU can establish agencies, branches, or subsidiaries in the territory of another member State.[170] Freedom of establishment extends to the EU subsidiaries of non-EU companies, but not to their branches or agencies.

146. EU member States have long maintained a policy of national treatment of foreign direct investment (FDI), subject to sector-specific restrictions. Empirical analysis shows that member States did not react to the recent financial and economic crisis by introducing new FDI restrictions.[171]

147. The overall level of restrictiveness on FDI in most EU member States is lower than the OECD average.[172] Luxembourg, the Netherlands, Portugal, Romania, and Slovenia maintain the lowest level of FDI restrictions among member States, and Poland the highest. On average, restrictions on FDI are highest in real estate, fishing, transport, agriculture, and media. They mostly take the form of equity limitations. Other barriers to FDI are requirements on key personnel and reciprocity requirements regarding investments from outside the EU (Box III.1). Member States' special rights in certain state-owned enterprises have also been found to restrict investment (see section (ii) below.

148. Several member States, including France, Germany, and the United Kingdom maintain FDI review procedures for national security purposes. During the period under review, Germany amended its Foreign Trade and Payments Act to broaden the scope of investment reviews. Under the amended Act, the Federal Ministry of Economics and Technology can examine foreign investment transactions to determine whether they jeopardize public interest or public security. Reviews are carried out only on transactions resulting in the acquisition of 25% or more of a resident company by investors from outside the EU or EFTA; transactions by EU-based companies may be examined if a non-EU shareholder owns 25% or more of the voting shares of that company if there are indications of abuse or circumvention.[173]

149. There are no notification requirements under Germany's investment review procedures. The Federal Ministry of Economics and Technology is responsible for determining whether a particular foreign investment transaction is covered by the Act. It uses information from the Federal Agency of Banking Supervision and the weekly lists of transactions issued by the Federal Competition Agency. In principle, the Ministry must decide whether to conduct a review within three months of the acquisition. It must issue an administrative act informing the companies concerned about the initiation of the review. Investors under review must submit the documents listed in the Federal Gazette of 24 April 2009.

150. Germany's Ministry of Economics and Technology may prohibit or impose conditions on a foreign investment transaction within two months of receiving the required information. The Ministry's decision is subject to judicial review. The Ministry has not prohibited or imposed conditions on any transaction under the amended Act. The Secretariat did not receive official data on the number of cases reviewed.

Box III.1: Reciprocity requirements in selected EU member States, December 2010 Austria: extraction, preparation, and storage of mass minerals; operation of oil refineries, gas plants, filling stations, and district heating; trading of fuels; investment in transport services, including road freight, taxis, buses; establishment of tour operators and travel agencies by non-resident entities Belgium:establishment of travel agencies by enterprises originating in non-EU member States France: establishment in the banking and financial services sector of non-resident investors originating in non-EU member States; establishment of insurance companies originating in non-EU member States; investment by non-EU residents in: political and general information publications appearing at least once per month (other than those intended for foreign communities in France) and audio-visual communication services; insurance brokerage; exploration, extraction, and exploitation of hydrocarbons, and waterfalls; and acquisition of agricultural land adjacent to the Swiss border Germany: establishment of airline enterprises with headquarters abroad Greece: establishment of travel agencies by enterprises originating in non-EU member states Ireland: foreign acquisition of shipping vessels registered in Ireland Italy: foreign investment in the exploration and exploitation of liquid and gaseous hydrocarbons; granting of tour operator and travel agent licences to nationals of non-EU member states, or to enterprises in such states United Kingdom: authorization of mergers and take-overs involving investors from non-EU member states Source: WTO Secretariat, based on OECD Code of Liberalization of Capital Movements, 2010. Viewed at: http://www.oecd.org/daf/investment/codes.

151. In Germany, prior to acquiring a resident company, foreign investors may request a certificate confirming that their acquisition does not compromise public policy or public security. Applications must be accompanied by a general outline of the planned acquisition, and information on the investors and their activities. If the Ministry of Economics and Technology does not launch an examination within one month of receiving an application, the certificate is deemed to be issued. Certificates are legally binding.

152. Under France's Decree 2005-1739, certain investments in "sensitive" sectors from companies whose corporate headquarters are outside the EU or the European Economic Area (EEA) are subject to notification and review.[174] These investments are reviewable if they result in: control of a firm with corporate headquarters in France; acquisition of a branch of a firm with corporate headquarters in France; or acquisition of more than one-third of the capital or voting rights of a firm with corporate headquarters in France.