March 2014 INVESTMENT CLIMATE Food Safety Toolkit Annexes Introduction 1-6 and and Bibliography Quick Start Guide Investment Climate l World Bank Group ©2014 The World Bank Group Table of Contents 1818 H Street N.W., Washington D.C., 20433 All rights reserved. March 2014 Available online at www.wbginvestmentclimate.org This work is a product of the staff of the World Bank Group with external contributions. The information included in this work, while based on sources that the World Bank Group considers to be reliable, is not guaranteed as to accuracy and does not purport to be complete. The World Bank Group accepts no responsibility for any consequences of the use of such data. The information in this work is not intended to serve as legal advice. Annex 1 - Justification and scope of World Bank Group involvement 5 The findings and views published are those of the authors and should not be attributed to IFC, the World Bank, the Multilateral Annex 2 - European legislation on food safety 27 Investment Guarantee Agency (MIGA), or any other affiliated organizations. Nor do any of the conclusions represent official policy of the World Bank or of its Executive Directors or the countries they represent. Annex 3 - Guidance notes 36 The denominations and geographic names in this publication are used solely for the convenience of the reader and do not imply the expression of any opinion whatsoever on the part of IFC, the World Bank, MIGA or other affiliates concerning the legal status of any Annex 4 - Suggested list of topics to be covered by training and workshops 37 country, territory, city, area, or its authorities, or concerning the delimitation of its boundaries or national affiliation. Annex 5 - Checklists 38 Rights and Permissions The material in this work is subject to copyright. Because the World Bank Group encourages dissemination of its knowledge, this work Annex 6 - List of food safety websites 41 may be reproduced, in whole or in part, for noncommercial purposes as long as full attribution of this work is given. Bibliography – further reading 43 Any queries on rights and licenses, including subsidiary rights, should be addressed to the Office of the Publisher, the World Bank, 1818 H Street NW, Washington, DC 20433, USA; telephone: 202-522-2422; email: pubrights@worldbank.org. About the Investment Climate Department of the World Bank Group The Investment Climate Department of the World Bank Group helps governments implement reforms to improve their business environments and encourage and retain investment, thus fostering competitive markets, growth, and job creation. Funding is provided by the World Bank Group (IFC, the World Bank, and MIGA) and over 15 donor partners working through the multidonor FIAS platform. Annex 1: Justification and scope of World Bank Group involvement Food safety is key for growth in the food-processing sector because it allows development of the local market as well as provides access to export markets. It thus has direct benefits for the private sector, in addition to its role in ensuring growth more broadly by reducing the burden of food-borne diseases. It is an important area where the International Finance Corporation and the Investment Climate Department of the World Bank Group have a specific role to play to improve the regulatory environment, which often acts as a barrier to development, access to markets, and investment. Demand for food safety regulatory reform can come from many quarters: domestic businesses, would-be exporters, retailers, foreign investors, etc. It is part of a broader set of changes as regulation is only one piece of the food safety puzzle. Many changes are simultaneously needed on the private sector side (how businesses actually work), as well as changes of behavior among consumers. Before getting involved in starting a food safety reform project, the Investment Climate De- partment of the World Bank Group has to clarify: • whether the proposed intervention fits with the World Bank Group mandate and strategy for the country and region; • that needs and demand for the intervention are sufficiently evidenced, and that there is real added value for intervention by the Investment Climate Department of the World Bank Group; and • what the realistic limitations are on the scope of the project. On the first point, this is a crowded space with many international organizations and donors. Therefore, the Investment Climate Department of the World Bank Group needs to play to its strengths. It needs to collaborate rather than compete with the other players and that means there has to be a strong private sector development reason for becoming involved. Although there are many technicalities in the field of food safety regulation, it is also fundamentally about developing markets and supporting the growth of the private sector. That is what proj- ects of the Investment Climate Department of the World Bank Group should focus on. Food safety regulation aims at “healthy markets” in addition to healthy people. It is also essential to know what the project will precisely focus on and aim to achieve. The field is too vast to just start a “food safety regulation” project without a clear objective. In parallel with defining the focus, it is also important to consider how a project will add value to that of others or will in some other way complement the projects of others. It is also absolutely essen- tial to check that there is a real demand for the project from policymakers and key institutions, and that there is a good chance of the project being successful even if there are changes in important personnel in the government. Annexes 1: Justification and Scope of World Bank Group Involvement 5 In terms of scope, the following main options should be considered, generally in some combi- nation as framework and implementation should be seen as complementary: • Revision of legislative framework – is this a critical pre-condition for further work, and does this involve only limited changes to roughly adequate legislation, or fundamental rewriting? If there is a need for fundamental rewriting, it is important to think through what will be needed in terms of implementation support. • Institutional reform – because food cuts across so many issues of government there is often confusion and overlap across both ministries and agencies. On this point reform can be limited reform (clarifying some problematic issues) or fundamental reform (setting up a whole new institutional framework). This has implications at the implementation level. • Process reform (changing how regulators organize and conduct their work) and implementation support – this is an essential part that can come as “stand alone” (if framework is generally right) or in complement to framework reform. The Investment Climate Department of the World Bank Group has expertise and a track record in inspections and licensing reforms, and other regulatory reform tools that are relevant to food safety reform implementation. Once the decision has been made for involvement by the Investment Climate Department of the World Bank Group, and the scope of the intervention is determined, a certain degree of training for World Bank Group staff would be helpful, particularly in supporting productive relations with collaborators who are experts in the food safety, such as the World Health Or- ganization and Food and Agriculture Organization. Annexes 1: Justification and Scope of World Bank Group Involvement 7 Role of and Results the the OIE (World Organization for Animal Health – in the veterinary health sphere) and IPPC (International Plant Learning from Investment the Climate Protection Convention – for plant health) set important parameters for primary production, which contribute FY08–11 Strategy Department of the to the continuum of safety along the food chain. The WTO has incorporated most of the norms elaborated World Cycle Bank Group by these institutions as part of its SPS rules. in food safety These international institutions set best practice that should be incorporated into national regulations. They also provide codes of practice and guidelines for imple- mentation. The FAO and the CAC, in particular, have Legislation should be based on the relevant existing developed sets of guidance documents that are very food safety policy of the country. Food safety policy helpful, and should be used in addition to this toolkit to is often The found as aof involvement part of Investment the an agricultural Climate or policy,Depart- provide further guidance and insights.1 When helping sometimes ment asWorld of the qu Group in food safety is rela- “food Bank countries with the development of food safety regula- tively recent, and limited in geographical scope, reach, tions, it is thus essential that the staff of the Invest- and breadth of issues addressed. In some cases, this ment Climate Department of the World Bank Group involvement can be seen as intruding on the legitimate pays attention to practices through which regulations sphere of other institutions, which have been active for are implemented and enforced (in particular inspec- a longer time in food safety, and for which it is part tions, testing, etc.) and support adjustment of practices of their core mandate. It is thus crucial to understand in line with international organizations’ recommenda- which institutions are involved, what their roles are, tions.2 Additional details on these institutions’ activities and where the Investment Climate Department of the are provided under section “Coordination”. World Bank Group can fit in and add value. Inside the World Bank Group, much of the work re- In the food safety area, the leading international institu- lated to strengthening and developing food safety tions are the Food and Agriculture Organization (FAO), systems has generally been (and still is) done by the from the food production angle, and the World Health World Bank’s agricultural or health teams (Sustainable Organization (WHO), from the human health perspec- Development Network), while other departments (for tive. The FAO and WHO are linked through the Codex example, Financial and Private Sector Development) Alimentarius Commission (CAC). The CAC was estab- may also be involved from a regulatory and quality in- lished by the FAO and WHO, and develops harmonized frastructure perspective. Projects sometimes focus on international food standards, guidelines, and codes of specific sectors (for example, animal production), or can practice. CAC standards and guidelines form the basis aim at the whole food safety system (for example, with of modern internationally accepted good food safety a view to achieving access to international markets, EU practices. accession or pre-accession). In most cases, these are not only advisory projects, but mainly investment projects FAO and WHO are the institutions that set the direction (for example, in laboratory networks, and other infra- in the food safety sphere, and coordination with them is structure), supported by advisory activities. In many in- essential. Other international organizations, particularly stances, these projects can be usefully complemented 1 The overall page for FAO guidance and publications on food 2 Countries, which seek admission to or association with the EU, safety is at: http://www.fao.org/food/food-safety-quality/ or a Free Trade Agreement with it, need to follow (or get as close home-page/publications-tools/en/ as possible to, if only free-trade is sought, and not membership Exhaustive list of publications is at: http://www.fao.org/ or quasi-membership) the EU official guidelines on Food Safety fileadmin/templates/agns/pdf/publications_list.pdf controls, which are contained in EC Regulation 882/2004, available at: Risk-based food inspection manual is at: http://www.fao.org/ docrep/010/i0096e/i0096e00.htm http://ec.europa.eu/food/food/controls/index_en.htm (along with relevant guidance documents etc.). Codex guide on import/export inspection/certification at: http:// www.fao.org/docrep/010/a1391e/a1391e00.htm Annexes 1: Justification and Scope of World Bank Group Involvement 9 by interventions by the Investment Climate Department of the Of all these institutions and actors, outside of the FAO and Focus on private sector development and growth Given that Investment Climate Department of the World Bank World Bank Group, but it is essential to first map correctly WHO, the EU is probably the most influential in the food Group usually intervenes in countries where regulatory inspec- what is being planned or implemented by the different de- safety sphere, for two reasons: Rather than a more “technical” food safety focus (as in WHO tions and enforcement tend to be highly rigid and “punish- partments of the World Bank, as these investment projects and FAO work), or an international trade angle (for the EU or ment oriented,” lack of appropriate guidance for businesses usually have a longer life-cycle, and a complex governance • The size of the EU makes it the main actor in international USAID), the primary goal of the Investment Climate Depart- and flexibility in understanding the new requirements is to be structure, meaning they are very difficult to change or steer food trade, and thus a key target market for existing ex- ment of the World Bank Group is private sector development, expected. Often, this fails to be taken into account by projects in another direction.Depending on the area of the world, re- porters of agricultural and food products, and for business- and this is the perspective from which they design and imple- with a narrower food safety or trade focus. gional institutions and bilateral or other multilateral donors es trying to start such exports (“would-be exporters”). ment food safety regulations projects. also play a key role. In particular, the EU has been supporting Imposing requirements that are not adapted to a country’s approximation of food safety regulations and regulatory sys- • As a multinational grouping, the EU has had to devote Advice and recommendations coming from projects with a stage of development is also a frequent, and major, problem. tems in countries that try and deepen their commercial ties considerable attention and efforts to developing a regu- strict “food safety” focus tend to not fully look at the cost/ This means foreseeing a system that is simply not realistic in to the EU (in particular in Eastern Europe and the former So- latory regime for food products that ensures a high level benefit aspect of changes, and to promote adoption of rules, terms of compliance, and where most actors will fail to com- viet Union). Countries that seek accession to the EU have to of safety and consumer confidence, allows flexibility, and regulations, and methods that are either excessively burden- ply (with enforcement being either absent, or becoming a entirely adopt the EU approach to food safety regulation and facilitates international trade. These characteristics make it some for local businesses, or not necessary to food safety im- source of corruption, as non-compliance is near universal). regulatory enforcement. The U.S. Agency for International in some ways the “reference” example for many countries provements, or unrealistic given the country’s development Development (USAID) is also frequently active in this sphere, trying to reform their own system. level (or any combination thereof). Similarly, trade-focused This can happen in several ways, for example, by ignoring similarly with an important trade aspect to its work (WTO projects can recommend wholesale adoption of regulations the extent to which a country relies on informal channels and accession context). Those donors often support projects that Although there are an important number of actors that have conforming to those in use in larger trade groupings (for ex- assuming that imposing new regulations and requirements are larger than those implemented by IFC or Investment Cli- prior presence in food safety regulation, there is an impor- ample, the EU), without consideration of whether they are will change things. In many countries, meat and dairy prod- mate Department of the World Bank Group, and can include tant role for the Investment Climate teams of the World Bank fully appropriate for the country, or what their cost may be ucts come mostly from informal channels. Even if the long- significant components of investment in equipment and in- Group to play in countries of intervention. Indeed, Investment for the local private sector. term aim is to change this situation and get most meat to frastructure needed to establish an effective food safety sys- Climate projects of the World Bank Group have a certain go through formal channels, designing appropriate regula- tem. Like World Bank investment projects, they tend to have number of specific strengths that are unique and constitute There are indeed several ways in which what some hold as tions requires taking the starting context into account and longer life-cycles and to be difficult to amend. Therefore, it a major complement and addition to the other donors’ and “gold standard” of food safety regulations may end up be- adopting a phased-in, gradual approach, to make sure that is very important for staff of IFC and Investment Climate De- institutions’ programs. ing more like “gold plating” (that is, excessive regulation that new regulations do not just become a source of rent-seeking partment of the World Bank Group to be fully aware of ex- “looks good” but does not provide real benefits commensu- for inspectors. Another related issue can be trying to impose isting or planned projects by bilateral or multilateral donors, The following subsections discuss the specific “space” of the rate to its costs). recent reforms from developed countries before essential pre- and to design new interventions so that they complement Investment Climate Department of the World Bank Group in requisites are in place (for example, mandating HACCP, which and leverage existing ones as much as possible. the food safety regulation sphere. Mandating standards that are highly burdensome (in admin- only became mandatory in the EU in 2006 before requiring istrative terms) and/or costly to comply with or to implement Good Hygiene Practices). Doing this can distract the food for businesses, without commensurate expected benefits is a business operators and regulators from focusing on putting major form of such “gold plating.” These standards can be the basis in place. They are instead pushed to focus on pro- excessively burdensome because they are taken directly from cess-management approaches that, though good in theory, countries that are members of the Organisation for Economic can only work once the fundamental elements are in place Co-operation and Development (OECD) or the EU, without (which itself can take quite a few years). consideration that they have not been fully subjected to such scrutiny in those countries. For example (many food safety Against this background, the Investment Climate Department rules from the 2004 EU “Hygiene Package”3 are not exempt of the World Bank Group can bring a different perspective to of such criticism inside the EU and should not necessarily all the reform process, one that takes into account: be adopted without consideration. Excessive burden can also arise because these norms are being imposed without the • economic impact (on growth, employment, incomes, necessary transition times and flexibility in implementation poverty); and enforcement. One example is the case of mandating a • feasibility (in terms of reaching broad compliance with HACCP-based approach, which is discussed in more detail in regulations); and Module 7. • risks (of disregard for the new regulations, corruption). 3 See Annex 1 for more details on the EU “Hygiene Package” 10 Investment Climate Food Safety Toolkit Annexes 1: Justification and Scope of World Bank Group Involvement 11 This should also mean involving more diverse stakeholders Flexibility to use a variety of approaches, rather Complementarities with other work of the On the Investment Climate side, a food safety intervention (in particular businesses) in the reform process. The key is to than “one size fits all” Investment Climate Department of the World should not limit itself to being an extension of licensing or emphasize that food safety regulation aims at healthy mar- Bank Group and the Sustainable Business inspections work. There may be many other areas that need kets too, in addition to healthy people. The end result should This may be one of the most crucial advantages and specifici- Advisory Business Line to be tackled (actual regulations and standards, certification not be a country where masses of businesses are just forced ties of interventions by the Investment Climate Department and standardization procedures), and the work may need to to close, or where inspectors find new sources of corruption of the World Bank Group in comparison with EU-funded Specific Investment Climate work on food safety regulations go significantly deeper (requiring specific expertise). because of unrealistic requirements or timelines. projects. Projects supported by the EU have an inherent goal usually builds on, or is accompanied with, other activities on to reach more approximation between local legislation and the Investment Climate Department of the World Bank Group Relative to the SBA side, the priorities should be complemen- Credibility with the government and the private regulatory practices and the EU. The Investment Climate De- and on the Sustainable Business Advisory (SBA) sides. tary but not necessarily always identical. For example, while sector partment of the World Bank Group can adapt its messages SBA projects are mostly promoting adoption and implemen- and recommendations to local country-specific conditions, SBA work focuses on developing capacity and uptake in the tation of HACCP practices (along with other major standards, In many countries, the Investment Climate projects of the without necessarily promoting a single model. private sector to implement best practice, internationally rec- such as those promoted by the GFSI) by target businesses, World Bank Group will have higher credibility and access to ognized approaches to food safety in processing operations. the investment Climate food safety work should only view the government and private sector than other donor projects. Such flexibility means that recommendations can be tailored Sectors of intervention are selected based on country priori- HACCP as one of the many tools available. Similarly, clients This is because of the World Bank Group’s status and to the development level and capacity (in the public and pri- ties and potential, and specific businesses are chosen based of the SBA food safety work can be important sources of influence, the prior engagement and track record of other vate sector) of the country; to the trade potential of its differ- on their capacity and readiness to invest significant resources information on current practices and potential changes, and Investment Climate projects of the World Bank Group, and ent agri-business sectors (depending which countries are the in this work. Other activities, depending on countries and should be among the stakeholders that are consulted and IFC’s profile as an organization focused on economic growth real targets for their exports, different regulatory models may contexts, may include public outreach to build understanding involved in the reform process. But they should not have a and private sector development. be more or less appropriate); and to regional integration is- of food safety issues, and support to policy changes. larger say than other business groups. sues. While the EU approach may remain a “reference point” While projects and donors focusing strictly on food safety or and a very good model in many ways, it is not the only pos- IC interventions in areas such as business licensing and inspec- These different specificities constitute a set of specific trade issues may have good access to their specific clients sible one. The ability to pick and choose makes sense for the tions (combined under Business Regulation) may prepare the strengths for food safety work of the Investment Climate and counterparts (usually Ministry of Agriculture or equiva- country of intervention, and what does not, is an important ground for similar work specifically in relation to food safety Department of the World Bank Group. They may not be all lent, possibly Ministry of Health and/or Commerce), the In- strength of the Investment Climate Department of the World and agribusiness. Alternatively, a broad intervention aimed applicable in each and every country, and their importance vestment Climate Department of the World Bank Group can Bank Group. at improving licensing or inspections of private businesses in will vary, but they build up the case for involvement by the have broader access (to Ministry of Economy, the office of general (regardless of sector/type) may be complemented by Investment Climate Department of the World Bank Group the prime minister or the president). It can also have the flex- ‘On the ground’ presence and ‘hands on’ advice deeper, more focused, sector-specific work on food-safety re- in this space. At the same time, it is a key priority to ensure ibility to work with diverse clients and counterparts (including lated regulations, licenses, and inspections. that intevention by the Investment Cimate department of the Parliament), which can be essential to driving complex, far- The Investment Climate Department of the World Bank Group World Bank Group intervention is not seen as an intrusion or ranging food safety regulatory reforms through. has a variety of intervention models in different countries, re- As a result, IC interventions focused on food safety can gen- a disruption. It is also essential to make sure recommenda- gions, and situations. In a number of cases, their projects are erally: tions are technically sound and aligned with good interna- A strong involvement with the private sector is also key to based on having a team of specialists permanently in coun- tional practices, but also take into consideration specifics of ensure reform is balanced and delivers realistic, achievable try, with a mix of profiles and expertise. Compared to typi- • build on broader IC work that to a large extent prepares each country. food safety requirements, with increased compliance and cal EU funded projects, the Investment Climate Department the ground for more specific reforms; and growth, rather than requirements that may be good “in of the World Bank Group employs a stronger share of local theory” but end up creating burden and harming the specialists, which gives them a better ability to understand • get better “buy in” and support from the business economy. the specifics of each country, and to convey their messages community, thanks to SBA interventions. to decision makers. The fact that the core team is composed of employees of the Investment Climate Department of the These are crucial advantages when it comes to promoting World Bank Group also gives them greater legitimacy and such complex and politically difficult reforms. This being said, access when delivering recommendations to client govern- it is important to be nonetheless cautious about potential pit- ments. All this can give, in specific situations, a better ability falls. to achieve deep policy changes compared to other project delivery models. 12 Investment Climate Food Safety Toolkit Annexes 1: Justification and Scope of World Bank Group Involvement 13 When to Results intervene and The key preconditions are demand from the client gov- ernment or the private sector and additionality – that because it may well happen that they have in some ways a “vested interest” in the current system (and anyway, institu- • Food safety regulations are a critical issue for business growth in the country, and no project is currently and with which Learning from the is, that the intervention would genuinely fill a gap, and not just come on top of existing or planned interven- tional resistance to change is very widespread). It is crucial to have sufficient (and stable) support from key sections of addressing it – nor is one being planned or developed in the near future. objectives FY08–11 Strategy tions by development partners for whom food safety is closer to their core mandate. political decision-making systems, depending on countries, constitutions, and political systems. This can mean the prime • Some projects exist, but cover only a fraction of the Cycle minister or president and/or their offices, key ministries, or food safety reforms that are needed. They do not really In terms of relevance, the essential parameters to con- key players in Parliament. tackle the most critical points for private sector and sider are the need for food safety regulations reform economic development. from the perspective of economic development and Preferably, the demand should be broad-based, cut across Given the above, it is clear that the Investment Climate business growth, and strategic fit with priorities de- different political parties and factions (for example, the re- • Existing projects are failing to reach results because they Department of the World Bank Group does not have fined by the International Finance Corporation and the form is an area of consensus), and include at least a signifi- lack the type of “convening power” or the stature for a to intervene mandate should Legislation be basedin the food on the safety existing relevant regulations World Bank Group for the country, region, and sector. cant part of the regulators themselves (such as some of the policy dialogue that the World Bank Group may have. sphere everywhere food safety policy ofand always. Its the country. mandate Food is not to safety policy top managers or agencies). It should not mean that projects improve food safety is often found or of as a part human health aspolicy, an agricultural such, or but to Preconditions – Demand should never be started in countries where demand/support • Approaches taken for reform are overly one-sided focus as “food development on economic sometimes qu through strengthen- is initially narrow and/or more fragile. In such cases, risks (emphasizing regulation at any cost), and threaten to ing of the private sector. This can, in some countries It is impossible for a project in this area to succeed or need to be adequately assessed and taken into account (the actually harm economic/business growth. and contexts, mean addressing growth bottlenecks even be justified if there is a lack of clear and solid de- reform might be stopped or even reversed if some core sup- created by inadequate food safety regulation. It is es- mand. But, as often with business regulation reforms, porters change functions or leave the scene). An important Relevance – Need sential, therefore, to define precisely which issues can the question can be: from whom? Indeed, demand can area of work for the project should be to broaden support, justify intervention by the Investment Climate Depart- (and should) come from the government, but also from for example, through public outreach activities, and seminars The need for food safety reform has to be defined, in the case ment of the World Bank Group in this area, and which businesses. Very often, it can happen that businesses involving key stakeholders and presenting successful foreign of involvement of the Investment Climate Department of the pre-conditions need to be met. (or at least some sections of the business population) experience. World Bank Group, not from a strict human health perspec- have a much stronger perception of the burden created tive, but from the perspective of economic and business de- It is important to clearly define, before inception, what by existing regulations (which can be a primary cause Preconditions – Additionality velopment. It may be that, in a given country, food safety is a the intervention by the Investment Climate Department for reforms) and of the limitations to their export po- very serious public health problem, but has no major impact of the World Bank Group is expected to achieve, and tential. Inside the government, views can differ strong- Whether involvement by the Investment Climate Department on economic growth other than that working days and lives what its scope will be. The food safety regulations field ly, depending on which ministry or structure is being of the World Bank Group in food safety reform will really bring due to sickness will always have an effect on the economy. is very broad, and Investment Climate projects of the considered. Ministries in charge of economy, business “additionality” is relatively easy to define in theory, but may For instance, if in that country food safety regulations do not World Bank Group can only cover a limited portion of development, and trade, are often far more likely to be be harder in practice. Indeed, this is not only about whether create any significant burden for business, or if there is no it. Because the exact breadth of issues to be addressed aware of problems with existing regulations, and sup- other actors are present or not. There may be other interven- serious existing or potential export opportunities which could varies in each country, some guidelines are needed on portive of changes, than the ministries and agencies tions existing (or planned), but they may not be covering the be harmed by poor food safety. what is possible, and how to determine the scope and that administer the regulatory system (for example, ag- whole field – or they may be missing some key issues, which limits of new projects. riculture, health, standards). are essential from the private sector perspective. The need for food safety reform can be defined from at least two angles: burden and export potential. Depending on the Justifications for intervention by the It is thus important to distinguish initial request for A less clear-cut situation may arise in cases where on paper country, both or only one of these might be present. Justifica- Investment Climate Department of the support from demand in the sense of real support for existing interventions are supposed to be addressing the rel- tion for intervention by the Investment Climate Department World Bank Group reform by key policymakers. This support can come evant issues, but in fact these interventions have an approach of the World Bank Group will only be present if at least one from the private sector, and/or from various parts of that disregards key private sector concerns, or harms the pri- of these is significant. Before the Investment Climate Department of the the government, and can be addressed through various vate sector (because it increases regulatory burden without World Bank Group intervenes in a country’s food safety means – local Investment Climate teams of the World consideration to cost/benefit issues, for instance). Or the ex- Such regulations often pose a burden and barrier to innova- regulatory system, certain preconditions have to be Bank Group, World Bank office, etc. “Demand” in this isting interventions may be failing at achieving real changes, tion and growth. Existing regulations impose a major admin- met, and issues have to be relevant to its mandate and sense can be gradually developed through initial inter- because of resistance by entrenched vested interests (a case istrative cost to businesses (often without being really effec- strategy. Any proposed intervention targeting the food actions with Investment Climate teams of the World that has frequently been observed). tive), be it in terms of licenses and permits, certificates, or safety regulatory system has to be justified in two ways: Bank Group public or private discussions involving the inspections. They also make starting a new business, launch- preconditions have to be met, and issues have to be private sector, foreign experts, or different ministries. In other words, additionality may be evidenced in different ing new food products, or using new technologies very dif- directly relevant to their mandate and strategy for the It does not need to always mean that the regulatory ways depending on the context: ficult. country and region being considered. agencies themselves are very supportive of reform 14 Investment Climate Food Safety Toolkit Annexes 1: Justification and Scope of World Bank Group Involvement 15 Export of key products (from agricultural or animal origin) or local level, or only in a given subsector. Decisions on how Scope of activities of the Investment Climate Scope in relation to sectors and regulators to essential markets is impossible, or very difficult. Alterna- to precisely structure a project should be taken based on the Department of the World Bank Group tively, export is possible but only to low-margin markets, or of strategic priorities (and of course the demand and starting Projects can be designed to either: low-margin products (raw products, lowest grade). In other situation – see above). It is not sufficient, as already suggested above, to ascertain words, the full export potential cannot be realized because that an intervention by the Investment Climate Department • support reform covering the whole food safety sphere, the highest-margin markets consider the food safety system In conclusion, interventions by the Investment Climate De- of the World Bank Group is justified (from the perspective of including all food types and production/processing of the country to be unsatisfactory. partment of the World Bank Group in food safety policy have need, demand, additionality, and strategic fit) – it is also nec- sectors, and all regulatory agencies (typically through to be carefully considered and justified in terms of need, de- essary to determine the scope of this intervention. framework legislation); mand, additionality, and strategic fit. In many cases, it may be Relevance – Strategic fit and complementarities appropriate to start by a limited and narrowly focused pilot, Indeed, the food safety policy field is very broad, and the • focus on a specific food supply chain or sector (such of interventions and expand it if demand is confirmed and experience shows range of issues that can be addressed considerable. The de- as dairy) and target all regulatory steps and actors that success is possible. gree to which specific points may be changed and reformed affecting it; or Overall, interventions by Investment Climate teams of the can also vary greatly. All these may also evolve over time, World Bank Group in the food safety regulations sphere fit from a pilot phase, which, if successful, can lead to a broader, • target only one regulatory process or regulatory agency, with the their strategies that put a strong emphasis on devel- more ambitious program. possibly combined with a focus on only one sector. oping the agricultural and agribusiness sectors, which pres- ent major opportunities for growth and job creation in many Objectives depend on the context: starting situation, po- The decision on scope is likely to affect the choice on depth parts of the world, in particular among “frontier” countries tential in terms of growth and exports, other sources of (see below), as limited resources will be available in any case, and regions. This is the justification for food safety policy re- assistance, government and private sector capacity etc. and will have to be spread thinner if the scope is wider. The form work to be an integral part of the “product offering” In particular, the reform work can focus on one sector (if main factors in this choice are, however, not primarily re- of the Investment Climate Department of the World Bank demand, need, capacity and/or strategic fit are stronger in sources (these will come as a limiting factor, and a secondary Group – but is not sufficient to form the basis for intervening this sector), or on one segment of the regulatory “chain” decision factor, of course) but needs and strategic priorities. in a particular country. The fit between the potential project (the most important, or the “low hanging fruit”). and the country- and region-specific strategies first needs to If problems, such as regulatory burden or lack of access to be evidenced, as well as the complementarity (if any) with foreign markets, cannot effectively be solved without reform- other World Bank Group interventions. ing the overall legislative framework for food safety, and there is real demand and support for this, then the project There are several strategic documents that should be re- will best be planned with a broad scope and the objective to viewed to check the relevance of a proposed project: World change the general legislation. Bank Group Country Strategy (usually Country Partnership Strategy, CPS – in some instances Country Assistance Strat- egy, CAS), International Finance Corporation Country Strat- egy, International Finance Corporation Advisory Services and Investment Regional Strategies – as well as strategic direc- tions for the development of the Industry Specific Investment Climate product line. The point is not to take a “tick box” approach but to really de- sign projects that effectively support these strategies (which themselves are essentially aligned and present different levels of details and emphasis). Food safety policy reform, if it is rel- evant to the World Bank Group strategy in a country, can be either developed as a stand-alone project, or embedded in a broader intervention (Investment Climate Department of the World Bank Group or Sustainable Business Advisory at IFC experimented as a pilot component, pursued at the national 16 Investment Climate Food Safety Toolkit Annexes 1: Justification and Scope of World Bank Group Involvement 17 On the other hand, if the potential for exports or the burden for growth primarily affect only one sector or supply chain, or • revision of existing law(s) or development of new law(s) on food safety – in order to create foundations The limitations Results and of prevent full integration in international trade. The proj- ect should be designed so that it effectively focuses on this sector is a major strategic priority for the country and the World Bank Group, and meaningful reforms can be achieved for a system in line with international practices, for example, through introduction or strengthening of FBO World Bank Learning from Group the these issues, and can have real impact, even if not all el- ements of the broader food safety system get reformed without changing the overall framework, and with a nar- rower focus, then the project can pick this sector as a focus liability for safety, planning of controls based on risk, clarification of mandates of different regulators, and FY08–11 Strategy interventions at the same time or pace. Cycle for activity. Similarly, if a single regulator is seen as a major traceability; Teams should conduct careful project planning to es- bottleneck, it may make sense to focus on this agency. timate what financial and human resources will be • changes in institutional structures, such as consolidation needed for each component and activity, and ensure These different approaches may be combined to different ex- of several agencies, clarification of respective roles of that they make realistic commitments. If resources are tents. For instance if the legislation is seen as a major problem different regulators, establishment of a coordination Just as important as defining when an intervention by insufficient for a component, and neither the client nor but there is little demand/support for broad reforms, then it and information sharing system between agencies, and the Investment Climate Department of the World Bank other development partners can take it up, the team may be appropriate to take a narrower focused or sectoral consolidation of laboratories; Group is legitimate Legislation should be and appropriate, based and what on the relevant it should existing should consider whether the project objectives can still approach. It may be that initial success in a narrower scope consist of, is food safety to know policy where of the it should country. Foodstop safety policythat – limits be achieved whether the reform will work without this project can build up support for broader action in the future. • reform of specific procedures or processes, such as should is often be foreseen found from as a part theagricultural of an start, so as not to policy, or cre- component being completed, whether it makes more It is also possible that both components progress in parallel: simplification/abolition of licenses or permits that are ate excessive sometimes asexpectations “food qu among clients, stakeholders, sense to drop the component entirely, or whether initi- broad reform limited to the top legislative level, and more not in line with international practices and create undue and development partners. ating work on it still makes sense because it can act to specific work for example on implementing regulations or burden, development of risk-based frameworks for encourage further reforms. procedures) concentrated on a specific sector, supply-chain inspections planning, and checklists for inspections; and First, the sheer scope, variety, and complexity of ele- and/or agency. ments of the food safety regulatory system essentially • Implementation of reform procedures, through rule out any intervention or project being really able to Need for coordination development of revised internal processes, design of address all issues. Depth – from legislation to processes and new information systems, training for staff, guidelines/ Resource limitations mean that it is crucial to under- institutional capacity procedures for samples taking, and laboratory testing. Second, there are inherent limitations linked first to stand which other donors may support components of budget and human resources issues, and also to the the reform that the Investment Climate Department of Reforming food safety issues can mean intervening on a va- In most cases, the specific role of the Investment Climate core competence and mandate of the Investment Cli- the World Bank Group cannot take care of, or which riety of levels – from the framework legislation (be it one law Department of the World Bank Group may limit the depth mate Department of the World Bank Group . While this donors may continue work initiated by the Investment on food safety or several laws or legislative acts) and reform of involvement at least on the fourth item. But the need to has partly been described above (Sections 4 and 5), it is Climate Department of the World Bank Group. of institutional structures (which agency or agencies are in achieve real, concrete results that change the situation in useful to specify these limitations a bit more precisely. charge of what) through regulatory procedures and pro- practice for businesses means that if the client clearly cannot The first requirement is to understand each of the other cesses (such as licenses, inspections, certificates) and safety handle this without assistance, and no other is forthcoming development partners’ mandate and core competence, requirements themselves (maximum residue levels, hygiene apart from the Investment Climate Department of the World Resource limitations as well as potential resources. While the available bud- standards) to strengthening of regulators’ capacity (staff Bank Group, it may be appropriate to include such points in gets will of course be country specific, with some or- training etc.). Projects can work on one, some, or all these the project. This should be seen as a general “menu” where Supporting the reform and improvement of the whole ganizations having a stronger focus on some types of levels, depending on needs, demand, priorities and presence teams will take specific elements depending on objectives, food safety regulations system would mean working countries or regions (based on income level, political (or absence) of other development partners – and, of course, initial conditions, needs and constraints that all have to be with all relevant agencies at all levels, from the leg- priorities, or geography), a quick typology is nonethe- availability of resources. clearly identified and stated. islation down to the training of staff, and working less possible: throughout the country. However, project size, budget, The levels of intervention can once again be phased, starting In practice, most projects will be a combination of some ele- and duration are always limited, and it is in practice World Bank – (investment operations – mostly Sus- with some targeted, lower level intervention and “escalating” ments of the above, and not always easy to categorize fully in impossible to have any project that would have such a tainable Development network but also Financial and if more support or resources are available and of course com- one or the other. This, however, gives an idea of the range of comprehensive approach. Private Sector Development, both investment and bined (intervening at different levels simultaneously). Agen- possible level of engagements and areas of focus. advisory operations). The focus can be on different is- cy-level interventions need not target all regulators involved It is important to make a choice between the range of sues, such as laboratories, supply chain improvement, in food safety, and can focus on the most important ones in In order to properly assess the situation in a particular coun- potential points of intervention, and identify, together overall regulatory and quality infrastructure (technical terms of objectives of the Investment Climate Department of try, a checklist is annexed to this toolkit to help define objec- with the clients and all stakeholders, the most critical, and food safety regulations, standards) or building the World Bank Group, or on the most ready to reform. tives and extent of actions needed. This will incorporate in- binding constraints that prevent the reform from mov- the capacity of the entire food safety control system. struments already created by the FAO and OIE, as well as the ing forward, unduly burden business development, and Breadth and depth differ. Common characteristics are Some of the activities that may be implemented at the differ- Investment Climate Department of the World Bank Group ent levels include supporting: experience. 18 Investment Climate Food Safety Toolkit Annexes 1: Justification and Scope of World Bank Group Involvement 19 potentially important funds available for equipment (labora- USAID – The agency’s projects tend to be increasingly large Focusing on core mandate and competences of To a lesser extent, the Investment Climate Department of the tories, Information technologies), staff training and similar and incorporate a variety of components. Food safety will the Investment Climate Department of the World World Bank Group can also be working on: resource-intensive activities, long project preparation times rarely be addressed as a stand-alone project, but will be an Bank Group (complex approval process), and delivery through Project element of trade facilitation or business development proj- • transformation of internal processes and organization Management Units embedded in the government structures. ects. As such, usually only a relatively narrow set of issues As clearly shown, the Investment Climate Department of the of agencies in charge of food safety regulation; Amounts available for advisory and technical assistance work is addressed. Projects funds are usually allocated to a mix of World Bank Group cannot cover every aspect of food safety • introduction of information systems for food safety vary significantly. Stand-alone advisory projects can exist if technical advice and equipment purchases. policy reforms, nor should they try to. In addition to selecting regulation; and donor funding is available. The “anchor” (headquarter teams priorities based on the needs and potential in the country, • training and capacity building of regulators’ staff. supporting operations throughout the world) has significant FAO – The agency is responsible for food and agriculture and and thus designing the project so as to address successfully expertise on food safety regulatory systems. jointly leading Codex Alimentarius work with the WHO. Its the most critical problems for the private sector, it is impor- In all areas, the specific the Investment Climate Department expertise is in the area on food safety regulatory systems and tant to understand what the Investment Climate Department of the World Bank Group value added should be to bring the Regional development banks (investment operations) – control systems. Small team in headquarters specializing on of the World Bank Group is most competent in, and what private sector perspective (or rather perspectives, as different Depending on the region, the bank can be the Asian Develop- these issues can be a source of expertise. But most operations its key strengths are in terms of experience and technical ex- types of businesses have different interests and concerns in ment Bank, African Development Bank, or the Inter-American are handled by regional offices. There may be small offices in pertise. such a reform) to the discussion and actions. Development. Through investment operations, banks may be country on a permanent basis. In some countries, FAO may able to provide significant support to equipment upgrades implement rather significant projects focusing on food safety, Building on the track record over several years and various In conclusion, there are limits inherent in what the the In- (laboratories, information technology), and staff training. mostly technical assistance (with possibly very limited equip- projects, and on the inherent strengths of the World Bank vestment Climate Department of the World Bank Group can ment), with different sources of ad hoc funding. It can be a Group, these areas of specialization can be summarized as focus on. Supporting the drafting of all substantive food European Commission (EC) – There are different instru- very important complement to the work of the Investment follows: safety requirements is more appropriate for organizations ments available depending on region and country. Budget Climate Department of the World Bank Group, or a basis on with far more of a technical focus on food safety like the support may be allocated for certain countries, in which case which to build further work as the FAO mostly deals with • Development or revision of framework legislation on FAO or WHO. The Investment Climate Department of the if the government puts food safety as a priority, and this is the setting up of the right framework, such as country food food safety World Bank Group can however, and should, point to gen- agreed with the EC delegation, important resources may be safety strategy and general legislation. • Introduction of risk-based planning of inspections eral directions of how these requirements can be developed available for equipment, staff training and similar expenses. • Improvements of inspection methods or changed (including, as suggested, translating the Codex Technical assistance, if present, is usually conducted primar- WHO – The agency is responsible for human health issues • Review and reform of licensing and permitting Alimentarius) and link clients with other organizations, more ily through EU consultants, which deliver high-level advice and jointly leading Codex Alimentarius work with FAO. It requirements suited to supporting this type of work. The Investment Cli- (reports), or targeted recommendations (for example, on a has considerable expertise in setting up effective food safety • Review of spheres of competence of different mate Department of the World Bank Group can also support specific legal document). Overall, the focus in technical as- systems, often supporting the development of country or re- institutions (institutional reform) work at the “business end” of things, such as the develop- sistance is on approximation of legislation and regulatory gional strategies to this effect, which can form a very useful • Development of strategic documents and action ment of checklists and guidelines for FBOs on how to comply practices with those of the EU. Typical projects will focus not basis for further work. It often has a representative office in programs with regulations. only on food safety but on approximation of trade-related country, which can provide specific input, and participate in laws and practices in general. Twinning projects are a specific high-level discussions. It sometimes may implement larger It is also essential to understand that what the Investment resource, in which case one or several EU-member states’ in- projects based on ad hoc donor funding. Operations are es- Climate Department of the World Bank Group can do and stitutions are “twinned” with a host country institution, such sentially managed at regional level. support will in most cases not be enough on their own to as a veterinary or standardization agency. In this case, mostly achieve deep and lasting changes. It can help initiate such advice is provided (through resident experts, visits and study OIE – Its focus is on veterinary issues, such as animal health changes but, to ensure real impact for the private sector and tours) but also some limited equipment. The advice is then at the breeding stage (epizootic control, etc), up to slaughter sustainability of changes, it is needed to embed such actions targeted (and can be targeted specifically at food safety), and level. It mostly implements diagnostic projects with high-level in a broader context of government programs, private sector can cover legislation and regulations but mostly focuses on recommendations. It provides authoritative advice on animal involvement, and assistance by other development partners. capacity building of the “twinned” institution. The limita- health issues, but has limited resources for projects. tion is that the project can then work nearly only with and through this institution. IPPC – This is a reference organization on plant protection. It does not normally implement projects, but issues guidelines. Annual Commission on Phytosanitary Measures (CPM) issues recommendations and guidelines. 20 Investment Climate Food Safety Toolkit Annexes 1: Justification and Scope of World Bank Group Involvement 21 Q1. Does proposed intervention fit World Bank Group NO STOP Dairy sector example Strategy for country and region? YES Obtain evidence YES Q1. Are we looking at the dairy sector as important and instrumental to supporting growth? If we have a strategy for the region, is dairy identified as part of it? Q2. Does evidence Q2.1 Does evidence exist that needs NO need to be NO Q2. What is the economic data around the dairy sector from farm to fork? Is it primary and demand for obtained? STOP intervention exist? production, that is, milk production as well as added value production such as milk, cheese, yoghurt, and other dairy derivative reliant products such as infant formula. Data should show annual outputs for the sector, national consumption YES requirements, and export potential. Is added value being lost to other countries, that is, is the milk produced being converted into other products in country or is this being done elsewhere? What other evidence do we need to justify intervention in Q3. Is there a real the dairy sector? What are the comparable markets and how do they differ? What ‘additionality’ for interventions in this sector have been successful? How much capacity is needed to IFC / World Bank Group NO STOP meet a growth in demand? intervention? Q3. What is World Bank Group bringing to the table in the dairy sector that others YES cannot? What expertise do we have in this sector and what other successes have we had in dairy added value products? Q4. Who do we need to collaborate with? Should it be WHO, FAO, or central and local Q4. Would governments, academia, businesses, and consumers? Dairy trade associations or Identify key collaborators IFC / World Bank YES agriculture expertise? Food production and processing technologists – international and devise collaboration need to collaborate strategy associations such as IuFOST? with others? Q5. Dairy sector demand may be high both nationally and internationally, but how NO sustainable is supply and can it meet demand? Is reform across the entire dairy supply chain required, that is, primary production right through to added value? Could we focus on one aspect of the sector, such as milk production, and still achieve success or do we need to succeed across the entire dairy sector supply Q5. Is there a high chance of failure? chain? YES STOP NO Devise scope of intervention Annexes 1: Justification and Scope of World Bank Group Involvement 23 Q1. Is revision of legislative framework YES Dairy sector example a critical pre condition for further work? NO Q1.1 Does this involve limited changes to YES roughly adequate legislation Q1. Is there existing legislation that applies to this sector? Does it cover a farm-to-fork approach? How rigorously is it enforced and by whom? What are the correlations Q2. Is there institutional NO between national legislation and International legislation? Codex dairy standards overlap currently? need to be considered as well as anything governing animal health and animal feed. YES Added value products derived from dairy will also require appropriate legislation and enforcement, such as milk, cheese, yoghurt, ready-to-eat foods with dairy derivatives, and infant formula. If the regulatory framework is sound, the focus NO Fundamental rewriting required (institutional should be on a risk-based approach to dairy sector revisions. If the regulatory rules) framework for this sector is weak or non existent, or does not cover the entire dairy food chain, then fundamental reform is required. Q3. Is limited reform required? Q2. Which ministries have regulatory responsibility for dairy? Does it overlap with food YES and animal health? How is legislation implemented and monitored? Have there been any dairy related outbreaks? NO Q3. If only limited reform is required, then problems need to be clarified in the context Clarify problematic issues of the entire supply chain for dairy products to ensure cohesion and shared responsibility. Q4. Is process reform Q4. If process reform is required, then organizing and conducting regulatory delivery is required? key. Animal health inspection needs to be considered in the context of dairy products YES production and distribution. Production and processing hazards should be identified and risks should be managed. There is a dearth of internationally agreed standards NO on this that can be used as a basis to understand what needs to be done. Control Make changes to the way measures for food safety hazards in dairy, such as pasteurisation, are well understood regulators organize and conduct their work around the world. Process reform implementation and support Annexes 1: Justification and Scope of World Bank Group Involvement 25 Annex 2: European legislation on food safety Food safety policy in the EU is defined as a key priority in the White Paper on Food Safety.1 The key elements of the EU food safety policy are: • use a risk-based approach; • use scientifically based international standards; • cover all steps in the food chain; • secure the same level of protection and control across the entire EU community; • inform the public about risks and ways to prevent and combat them; and • present requirements to trade partners outside the EU.. Regulation (EC) 178/2002 lays down these principles and outlines a model to be followed when developing a food safety law in the EU member states. Those principles are: • high level of protection of human health, consumers’ interests and, where necessary, animal and plant health and the environment; • implementation of international standards whenever they exist, and use of other standards only when no international standards exist and until they are developed; • “Farm-to-fork” regulations and measures to cover all stages of food production, processing, transportation, retail, and catering; • Risk analysis – a three-tier system to be introduced and implemented by official bodies in policymaking and enforcement; • “Precautionary principle” when there is a risk of harmful effect on human health, animal, or plan health. Management of that risk can be performed by ad hoc measures only if scientifically based measures do not exist for that risk. Such measures should be replaced with scientifically based ones, as soon as they are developed, or remain in force if proved to be scientifically sound and effective; • food and feed imported into the EU market from third countries shall have the equivalent food safety characteristics as food produced in EU member states. If there is a specific agreement between a third country and EU member state, than food must comply with provisions stated in that agreement; • transparency is important when developing food laws and measures, and when estimating their impacts. Involvement of all stakeholders (authorities, private sector, associations of producers, scientific community, NGOs, chambers of commerce, international trading partners, trade organizations) is recommended; • primary responsibility of food business operators for safety of food they place on the market; • food business operators are responsible for fulfilling all regulatory requirements concerning food and feed; • implementation of the preventive approach to control of hazards is at all levels of food and feed production, circulation and use; • presentation of food and feed that does not mislead consumers; and • Securing traceability along the food chain at least as “one step down-one step up.” http://ec.europa.eu/dgs/health_consumer/library/pub/pub06_en.pdf 1 Annexes 2: European legislation on food safety 27 In addition, a “hygiene package” group of regulations aiming to produce consistency in the food chain was The implementation of the “hygiene package” was supported then with: developed, namely: • microbiological criteria for food stuffs: Regulation (EC) 2073/2005—a regulation laying down principles for • General hygiene: Regulation (EC) 852/2004 on the hygiene of foodstuffs2 (including its updates and representative sampling, types of microbes to look for as signs of safety of food, methods according to which regulations that are developed later dealing with particular operations3), which states that: microbes should be tested, places in the food chain to look for microbes according to type of products/technol- • primary responsibility for food safety rests with the food business operator; ogy used; • food safety should be ensured from primary production to end consumer; • implementing measures for certain products under Regulations (EC) 852, 853, 854, 882 and transitional mea- • cold chain must be respected and food kept at the temperature needed for that type of food; sures until the “hygiene package” was not fully in force; • GHP and GMP need to be implemented in order to reinforce food business operator’s responsibility and to • legislation on animal welfare—setting the rules on keeping animals according to best practices; and create a solid basis for a functional food safety system; • food safety systems based on HACCP principles should be considered for export oriented companies and/or • National legislation of EU member states: It is important to emphasize that Regulation (EC) 852/2004 and major food producers; Regulation (EC) 853/2004 grant exemptions to certain specified activities if they are regulated by national rules • microbiological criteria and temperature requirements (for specific technological operations) must be based in such a way that they ensure the achievement of the objectives of the EU regulations (for example, Ireland: on up-to-date solid scientific grounds; and slaughtering outside licensed slaughterhouses, some activities in butcher shops; Bulgaria: small and medium • imported food shall be of the same hygiene level or higher than that produced in the country of import. sized milk producers; Germany: regulations on feed, regulations on meat and poultry). • Food of animal origin: Regulation (EC) 853/2004 laying down specific hygiene rules for food of animal There are also EU guidance notes on certain provisions in regulations belonging to the “hygiene package” and origin,4 such as: other pieces of regulation dealing with specific problems. A list of such regulations in food safety, veterinary, and • detailed requirements for qualifying FBOs in particular with respect to traceability and recall, and most phytosanitary areas is given below. significantly HACCP; 1. Regulation (EC) No 178/2002 of the European Parliament and of the Council of January 28 2002 laying down • prerequisite requirement specifics; the general principles and requirements of food law, establishing the European Food Safety Authority and laying • requirements for inspectors enforcing the provisions to have specialist knowledge and training; and down procedures in matters of food safety • list of product categories to which this regulation relates: minced meat, meat preparations, mechanically amended by: separated meat, meat products, live bivalve molluscs (shellfish), fishery products, dairy products, eggs (not primary production)/egg products, frogs’ legs/snails, rendered animal fats and greaves, treated stomachs, • Regulation (EC) No 1642/2003 of the European Parliament and of the Council of July 22 2003 amending bladders and intestines, gelatine, collagen. Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. Regulation (EC) 854/2004 laying down specific rules for the organization of official controls on products of animal • Commission Regulation (EC) No 575/2006 of April 7 2006 amending Regulation (EC) No 178/2002 of the Euro- origin intended for human consumption, namely: pean Parliament and of the Council as regards the number and names of the permanent scientific panels of the • specific requirements on approval of establishments from which food can be traded in the EU market; European Food Safety Authority. • list of issues to be controlled within one establishment; • Commission Regulation (EC) No 202/2008 of March 4 2008 amending Regulation (EC) No 178/2002 of the Eu- • how control of hazards should be performed with specific interest in the HACCP system in place; ropean Parliament and of the Council as regards the number and names of the scientific panels of the European • how verification of control is performed; Food Safety Authority. • risk-based control principles; • Regulation (EC) No 596/2009 of the European Parliament and of the Council of June 18 2009 adapting a num- • specifics of control of: fresh meat, live bivalve molluscs, fishery products, raw milk and dairy products; and ber of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/ • list of third countries and their establishments from which export to the EU is allowed. EC with regard to the regulatory procedure with scrutiny. Regulation (EC) 882/2004 on official controls performed to ensure verification of compliance with feed and food law. implementing acts: Animal health and animal welfare rules regulate: • Commission Regulation (EC) No  2230/2004 of December 23, 2004, laying down detailed rules for the imple- • general obligations of control bodies; mentation of European Parliament and Council Regulation (EC) No 178/2002 with regard to the network of • capacities to be in place in so called “competent authorities” (control bodies) and their operational criteria; organizations operating in the fields within the European Food Safety Authority’s mission. • delegation of specific tasks to different control bodies; • Commission Decision 2004/478/EC of April 29, 2004, concerning the adoption of a general plan for food/feed • requirements related to control body’s staff; crisis management. • principles of transparency and confidentiality; • procedures needed for efficient control and verification; • Commission Regulation (EU) No 16/2011 of January 10, 2011, laying down implementing measures for the • sampling and analysis in officially designated laboratories, reference laboratories; Rapid Alert System for Food and Feed. • crisis management, 2. Regulation 183/2005 of the European Parliament and of the Council of January 12, 2005, laying down require- • principles of control of food and feed coming from countries third countries; ments for feed hygiene. • principles upon which control plans should be made; 3. Directive 2002/32/EC of the European Parliament and of the Council of May 7, 2002, on undesirable substances • how certificates on animal health should be issued; and in animal feed. • reporting and financing. 4. Regulation (EC) No 767/2009 of the European Parliament and of the Council of July 13, 2009, on the placing 2 Consolidated version 2004R0852 — EN — 20.04.2009 — 002.001 — 1 on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 3 Example: although pasteurization of milk was regulated by the Regulation EC 852/2004, updated rules are given in the Regulation EC 605/2010 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 4 Consolidated version 2004R0853 — EN — 11.03.2011 — 009.001 — 1 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC. 28 Investment Climate Food Safety Toolkit Annexes 2: European legislation on food safety 29 5. Regulation (EC) No  882/2004  of the European Parliament and of the Council of April  29, 2004, on official 18. Regulation (EC) No  1830/2003 of the European Parliament and of the Council of September 22, 2003, con- controls performed to ensure the verification of compliance with feed and food law, animal health, and animal cerning the traceability and labelling of genetically modified organisms and the traceability of food and feed welfare rules. products produced from genetically modified organisms and amending Directive 2001/18/EC. amended by: 19. Regulation (EC) No 1831/2003 of the European Parliament and of the Council of September 22, 2003, on ad- • Commission Regulation (EC) No 1029/2008 of October 20, 2008, amending Regulation (EC) No 882/2004 of ditives for use in animal nutrition. the European Parliament and of the Council to update a reference to certain European standards. 20. Council Directive 98/58/EC of July 20, 1998, concerning the protection of animals kept for farming purposes. implementing acts: 21. Council Directive 2007/43/EC of June 28, 2007 laying down minimum rules for the protection of chickens kept • Commission Regulation (EC) No 1162/2009 of November 30, 2009, laying down transitional measures for the for meat production. implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European 22. Council Directive  1999/74/EC  of July 19, 1999, laying down minimum standards for the protection of laying Parliament and of the Council. hens. • Commission Regulation (EC) No 669/2009 of July 24, 2009, implementing Regulation (EC) No 882/2004 of the 23. Council Directive  2008/120/EC  of December 18, 2008, laying down minimum standards for the protection of European Parliament and of the Council on the increased level of official controls on imports of certain feed and pigs. food of non-animal origin and amending Decision 2006/504/EC. 24. Council Directive  2008/119/EC  of December 18, 2008, laying down minimum standards for the protection of 6. Regulation (EC) No 852/2004 of the European Parliament and of the Council of April 29, 2004, on the hygiene calves. of foodstuffs. 25. Council Regulation (EC) No 1/2005 of December 22, 2004, on the protection of animals during transport and 7. Regulation (EC) No  853/2004  of the European Parliament and of the Council, of April 29, 2004, laying down related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97. specific hygiene rules for food of animal origin. Council Regulation (EC) No  1099/2009 of September 24, 2009, on the protection of animals at the time of 8. Regulation (EC) No 854/2004 of the European Parliament and of the Council of April 29, 2004, laying down killing. specific rules for the organization of official controls on products of animal origin intended for human consump- 26. Regulation (EC) No 2160/2003 of the European Parliament and of the Council of November 17, 2003, on the tion. control of salmonella and other specified foodborne zoonotic agents. implementing acts: 27. Council Directive  2003/85/EC  of September 29, 2003, on Community measures for the control of foot-and- • Commission Regulation (EC) No  2074/2005  of 5  December  2005 laying down implementing measures for mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Direc- certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for tive 92/46/EEC. the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the 28. Council Directive 2000/75/EC of November 20, 2000, laying down specific provisions for the control and eradi- Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from cation of bluetongue. Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) 29. Council Directive 2001/89/EC of October 23, 2001, on Community measures for the control of classical swine No 853/2004 and (EC) 854/2004. fever. 9. Commission Regulation (EC) No 2073/2005 of November 15, 2005, on microbiological criteria for foodstuffs. 30. Council Directive 2002/60/EC of June 27, 2002, laying down specific provisions for the control of African swine 10. Council Directive  82/894/EEC  of December 21, 1982, on the notification of animal diseases within the Com- fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever. munity. 31. Regulation (EC) No 1107/2009 of the European Parliament and of the Council of October 21, 2009, concerning 11. Regulation (EC) No  999/2001  of the European Parliament and of the Council of May 22, 2001, laying down the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/ rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies.  EEC. 12. Regulation (EC) No 1069/2009 of the European Parliament and of the Council of October 21, 2009, laying down 32. Regulation (EC) No 1610/96 of the European Parliament and of the Council concerning the creation of a supple- health rules on animal by-products and derived products not intended for human consumption and repealing mentary protection certificate for plant protection products. Regulation (EC) No 1774/2002. 33. Directive  2009/128/EC  of the European Parliament and of the Council of October  21, 2009, establishing a 13. Council Directive  2002/99/EC  of 12 December 12, 2002, laying down the animal health rules governing the framework for community action to achieve the sustainable use of pesticides. production, processing, distribution, and introduction of products of animal origin for human consumption. 34. Regulation (EC) No  396/2005  of the European Parliament and of the Council of February 23, 2005, on maxi- 14. Council Regulation (EC) No 834/2007 of June 28, 2007, on organic production and labelling of organic products mum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Direc- and repealing Regulation (EEC) No 2092/91. tive 91/414/EEC. 15. Regulation (EC) No 219/2009 of the European Parliament and of the Council of March 11, 2009, adapting a 35. Directive 98/8/EC of the European Parliament and of the Council of February 16, 1998, concerning the placing number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision of biocidal products on the market. 1999/468/EC with regard to the regulatory procedure with scrutiny. 36. Council Directive  2000/29/EC  of May 8, 2000, on protective measures against the introduction into the com- 16. 2009/821/EC: Commission Decision of September 28, 2009, drawing up a list of approved border inspection munity of organisms harmful to plants or plant products and against their spread within the community. posts, laying down certain rules on the inspections carried out by Commission veterinary experts and laying 37. Council Regulation (EEC) No 315/93 of February 8, 1993, laying down community procedures for contaminants down the veterinary units in TRACES. in food. 17. Regulation (EC) No 1829/2003 of the European Parliament and of the Council of September 22, 2003, on ge- 38. Commission Regulation (EC) No 1881/2006 of December 19, 2006, setting maximum levels for certain contami- netically modified food and feed. nants in foodstuffs. 30 Investment Climate Food Safety Toolkit Annexes 2: European legislation on food safety 31 39. Regulation (EC) No 2003/2003 of the European Parliament and of the Council of October 13, 2003, relating to 59. Council Directive 91/496/EEC of July 15, 1991, laying down the principles governing the organization of vet- fertilizers. erinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 40. Council Directive  91/676/EEC  of December  12, 1991, concerning the protection of waters against pollution 90/425/EEC and 90/675/EEC. caused by nitrates from agricultural sources.  60. Commission Regulation (EC) No 282/2004 of February 18, 2004, introducing a document for the declaration of, 41. Commission Regulation (EC) No 2023/2006 of December 22, 2006, on good manufacturing practice for materi- and veterinary checks on, animals from third countries entering the Community. als and articles intended to come into contact with food. 61. Council Directive 90/427/EEC of June 26, 1990, on the zootechnical and genealogical conditions governing 42. Regulation (EC) No 1935/2004 of the European Parliament and of the Council of October 27, 2004, on materials intra-Community trade in equidae. and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC. 62. Council Directive 90/428/EEC of June 26, 1990, on trade in equidae intended for competitions and laying down 43. Commission Regulation (EU) No 10/2011 of January 14, 2011, on plastic materials and articles intended to come the conditions for participation therein. into contact with food. 63. Council Directive 91/68/EEC of January 28, 1991, on animal health conditions governing intra-community trade 44. Directive 2001/18/EC of the European Parliament and of the Council of March 12, 2001, on the deliberate re- in ovine and caprine animals. lease into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. 64. Council Directive 2003/50/EC of June 11, 2003, amending Directive 91/68/EEC as regards reinforcement of 45. Directive 2009/41/EC of the European Parliament and of the Council of May 6, 2009, on the contained use of controls on movements of ovine and caprine animals. genetically modified micro-organisms. 65. Council Directive 90/425/EEC of June 26, 1990, concerning veterinary and zootechnical checks applicable in 46. Regulation (EC) No 1946/2003 of July 15, 2003, of the European Parliament and of the Council on transbound- intra-Community trade in certain live animals and products with a view to the completion of the internal mar- ary movement of genetically modified organisms. ket. 47. Council Regulation (Euratom) No  3954/87  of December 22, 1987, laying down maximum permitted levels of 66. Regulation (EC) No 998/2003 of the European Parliament and of the Council of May 26, 2003, on the animal radioactive contamination of foodstuffs and of feedingstuffs following a nuclear accident or any other case of health requirements applicable to the non-commercial movement of pet animals and amending Council Direc- radiological emergency. tive 92/65/EEC. 48. Council Decision  2003/822/EC  of November 17, 2003, on the accession of the European Community to the 67. Council Directive 90/539/EEC of October 15, 1990, on animal health conditions governing intra-Community Codex Alimentarius Commission. trade in, and imports from third countries of, poultry and hatching eggs. 49. Commission Regulation (EC) No 41/2009 of January 20, 2009, concerning the composition and labelling of 68. Council Directive 2006/88/EC of October 24, 2006, on animal health requirements for aquaculture animals and foodstuffs suitable for people intolerant to gluten. products thereof, and on the prevention and control of certain diseases in aquatic animals. 50. Directive 2000/13/EC of the European Parliament and of the Council of March 20, 2000, on the approximation 69. Council Directive 64/433/EEC of June 26, 1964, on health problems affecting intra-Community trade in fresh of the laws of the member states relating to the labelling, presentation and advertising of foodstuffs. meat. 51. Regulation (EC) No 258/97 of the European Parliament and of the Council of January 27, 1997, concerning 70. Council Directive 71/118/EEC of February 15, 1971, on health problems affecting trade in fresh poultry meat. novel foods and novel food ingredients. 71. Council Directive 91/495/EEC of November 27, 1990, concerning public health and animal health problems af- 52. Council Directive 2006/88/EC of October 24, 2006, on animal health requirements for aquaculture animals and fecting the production and placing on the market of rabbit meat and farmed game meat. products thereof, and on the prevention and control of certain diseases in aquatic animals. 72. Council Directive 92/45/EEC of June 16, 1992, on public health and animal health problems relating to the kill- 53. Council Directive 92/65/EEC of July 13, 1992, laying down animal health requirements governing trade in and ing of wild game and the placing on the market of wild-game meat. imports into the community of animals, semen, ova, and embryos not subject to animal health requirements laid 73. Council Directive 92/46/EEC of June 16, 1992, laying down the health rules for the production and placing on down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC. the market of raw milk, heat-treated milk and milk-based products. 54. Commission Regulation (EU) No 206/2010 of March 12, 2010, laying down lists of third countries, territories or 74. Council Directive 97/78/EC of December 18, 1997, laying down the principles governing the organisation of parts thereof authorised for the introduction into the EU of certain animals and fresh meat and the veterinary veterinary checks on products entering the Community from third countries and repealing Directive 90/675/ certification requirements. EC. 55. Commission Regulation (EC) No 1398/2003 of August 5, 2003, amending Annex A to Council Directive 92/65/ 75. Council Directive 89/662/EEC of December 11, 1989, concerning veterinary checks in intra-Community trade EEC to include the small hive beetle (Aethina tumida), the Tropilaelaps mite (Tropilaelaps spp.), Ebola and mon- with a view to the completion of the internal market. key pox. 76. Council Directive 2001/110/EC of December 20, 2001, relating to honey. 56. Regulation (EC) No 470/2009 of the European Parliament and of the Council of May 6, 2009, laying down Com- 77. Council Directive 88/407/EEC of June 14, 1988, laying down the animal health requirements applicable to intra- munity procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs Community trade in and imports of semen of animals of the bovine species. of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of 78. Council Directive 2003/43/EC of May 26, 2003, amending Directive 88/407/EEC laying down the animal health the Council (Text with EEA relevance ). requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species. 57. Council Directive 64/432/EEC of June 26, 1964, on animal health problems affecting intra-Community trade in bovine animals and swine. 79. Council Directive 89/556/EEC of September 25, 1989, on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species. 58. Council Directive 2004/68/EC of April 26, 2004, laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/ EEC and repealing Directive 72/462/EEC. 32 Investment Climate Food Safety Toolkit Annexes 2: European legislation on food safety 33 80. Council Directive 2008/73/EC of July 15, 2008, simplifying procedures of listing and publishing information in 100. Council Directive 96/23/EC of April 29, 1996, on measures to monitor certain substances and residues thereof the veterinary and zootechnical fields and amending Directives 64/432/EEC, 77/504/EEC, 88/407/EEC, 88/661/ in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/ EEC, 89/361/EEC, 89/556/EEC, 90/426/EEC, 90/427/EEC, 90/428/EEC, 90/429/EEC, 90/539/EEC, 91/68/EEC, EEC and 91/664/EEC. 91/496/EEC, 92/35/EEC, 92/65/EEC, 92/66/EEC, 92/119/EEC, 94/28/EC, 2000/75/EC, Decision 2000/258/EC and 101. Council Directive 96/22/EC of April 29, 1996, concerning the prohibition on the use in stockfarming of certain Directives 2001/89/EC, 2002/60/EC and 2005/94/EC. substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 81. Council Directive 92/65/EEC of July 13, 1992, laying down animal health requirements governing trade in and 88/146/EEC and 88/299/EEC. imports into the Community of animals, semen, ova, and embryos not subject to animal health requirements 102. Commission Directive 2002/72/EC of August 6, 2002, relating to plastic materials and articles intended to come laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC. into contact with foodstuffs. 82. Council Directive 90/429/EEC of June 26, 1990, laying down the animal health requirements applicable to intra- 103. Commission Regulation (EC) No 282/2008 of March 27, 2008, on recycled plastic materials and articles intended Community trade in and imports of semen of domestic animals of the porcine species. to come into contact with foods and amending Regulation (EC) No 2023/2006. 83. Commission Directive 98/67/EC of September 7, 1998, amending Directives 80/511/EEC, 82/475/EEC, 91/357/ 104. Commission Directive 2007/42/EC of June 29, 2007, relating to materials and articles made of regenerated cel- EEC and Council Directive 96/25/EC and repealing Directive 92/87/EEC. lulose film intended to come into contact with foodstuffs. 84. Commission Directive 2003/57/EC of June 17, 2003, amending Directive 2002/32/EC of the European Parlia- 105. Commission Regulation (EC) No 450/2009 of May 29, 2009, on active and intelligent materials and articles ment and of the Council on undesirable substances in animal feed. intended to come into contact with food. 85. Commission Directive 2003/100/EC of October 31, 2003, amending Annex I to Directive 2002/32/EC of the 106. Council Directive 82/711/EEC of October 18, 1982, laying down the basic rules necessary for testing migration European Parliament and of the Council on undesirable substances in animal feed. of constituents of plastic materials and articles intended to come into contact with foodstuffs. 86. Commission Directive 2002/70/EC of July 26, 2002, establishing requirements for the determination of levels of 107. Council Directive 78/142/EEC of January 30, 1978, on the approximation of the laws of the member states relat- dioxins and dioxin-like PCBs in feedingstuffs. ing to materials and articles that contain vinyl chloride monomer and are intended to come into contact with 87. Council Decision 78/923/EEC of June 19, 1978, concerning the conclusion of the European Convention for the foodstuffs. protection of animals kept for farming purposes. 108. Commission Regulation (EC) No 1895/2005 of November 18, 2005, on the restriction of use of certain epoxy 88. Council Directive 2001/88/EC of October 23, 2001, amending Directive 91/630/EEC laying down minimum derivatives in materials and articles intended to come into contact with food. standards for the protection of pigs. 108. Council Directive 84/500/EEC of October 15, 1984, on the approximation of the laws of the Member States 89. Commission Directive 2001/93/EC of November 9, 2001, amending Directive 91/630/EEC laying down mini- relating to ceramic articles intended to come into contact with foodstuffs. mum standards for the protection of pigs. 110. Council Regulation (EEC) No 737/90 of March 22, 1990, on the conditions governing imports of agricultural 90. Council Directive 1999/74/EC of July 19, 1999, laying down minimum standards for the protection of laying products originating in third countries following the accident at the Chernobyl nuclear power station. Extended hens amended by Council Regulation (EC) No 806/2003 of 14 April 2003. by Council Regulation (EC) No 686/95 of March 28, 1995, and Council Regulation (EC) No 616/2000 of 20 91. Council Directive 93/119/EC of December 22, 1993, on the protection of animals at the time of slaughter or March 2000. Amended by: Council Regulation (EC) No 806/2003 of April 14, 2003. killing. 111. Council Regulation (EEC) No 2219/89 of July 18, 1989, on the special conditions for exporting foodstuffs and 92. Council Regulation (EC) No 1099/2009 of September 24, 2009, on the protection of animals at the time of kill- feedingstuffs following a nuclear accident or any other case of radiological emergency. ing. 112. Council Decision 87/600/EEC of December 14, 1987, on Community arrangements for the early exchange of 93. Regulation (EC) No 1523/2007 of the European Parliament and of the Council of December 11, 2007, banning information in the event of a radiological emergency. the placing on the market and the import to, or export from, the Community of cat and dog fur, and products 113. Regulation (EC) No 299/2008 of the European Parliament and of the Council of March 11, 2008, amending containing such fur. Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and ani- 94. Regulation (EC) No 1007/2009 of the European Parliament and of the Council on trade in seal products. mal origin, as regards the implementing powers conferred on the Commission. 95. Council Regulation (EC) No 1255/97 of June 25, 1997, concerning Community criteria for staging points and amending the route plan referred to in the Annex to Directive 91/628/EEC. 96. Council Decision 88/306/EEC of May 16, 1988, on the conclusion of the European Convention for the Protec- tion of Animals for Slaughter. 97. Council Directive 86/609/EEC of November 24, 1986, on the approximation of laws, regulations and admin- istrative provisions of the member states regarding the protection of animals used for experimental and other scientific purposes. 98. Council Decision 2006/507/EC of October 14, 2004, concerning the conclusion, on behalf of the European Community, of the Stockholm Convention on Persistent Organic Pollutants. 99. Council Directive 88/344/EEC of June 13, 1988, on the approximation of the laws of the member states on extraction solvents used in the production of foodstuffs and food ingredients. 34 Investment Climate Food Safety Toolkit Annexes 2: European legislation on food safety 35 Annex 3: Results and Annex 4: Learning from the Guidance notes Suggested list of topics to be covered by training and workshops FY08–11 Strategy I. FAO Model Food Law: http://www.fao.org/ag/agn/food/pdf/foodlaw.pdf Cycle Potential participants Type of training II. EC White Paper on Food Safety: http://ec.europa.eu/dgs/health_consumer/library/pub/pub06_en.pdf Food safety – general principles and requirements; food III. Guidance notes on Regulation (EC) 852/2004: Regulators, private sector, public, journalists quality and safety Regulators, inspectors, private sector, academia, International standards and regulations at different export • Commission staff working document on the understanding of certain provisions on flexibility provided in the laboratories markets hygiene package – Guidelines for the competent authorities Regulators, inspectors, private sector, academia, Hygiene of food, Regulation EC 852/2004 and Regulation • Commission Legislation should staff working be based document on the relevanton the understanding of certain provisions on flexibility provided in the existing laboratories EC 853/2004 hygiene package (Frequently Asked Questions food safety policy of the country. Food safety policy - Guidelines for food business operators ) Regulators, inspectors Risk-based inspection and Regulation EC 854/2004 is often found as a part of an agricultural policy, or • Guidance document on the implementation of certain provisions of Regulation (EC) No 852/2004 on the Principles of risk analysis as basis for regulations and sometimes “food as of hygiene qu foodstuffs Regulators, inspectors, private sector, academia measures Academia Risk assessment methodology • Guidance document on the implementation of procedures based on the HACCP principles, and facilitation of the implementation of the HACCP principles in certain food businesses Regulators, inspectors, private sector, academia, GMP, GHP, HACCP laboratories Inspectors, farmers GAP Guidelines for the development of community guides to good practice for hygiene or for the application of the HACCP principles in accordance with Article 9 of Regulations (EC) No 852/2004 on the Hygiene of Inspectors, private sector Preparation of checklists Foodstuffs and Article 22 of Regulation (EC) No 183/2005 laying down requirements for feed hygiene Border inspectors, customs Border control of food safety, animal and plant health Modern microbiological methods, Regulation EC IV. Guidance notes on certain provisions of Regulation (EC) No 853/2004 published by the European Laboratories (official, private, from food producing 2073/2005, quick methods for detection of pathogens and Commission: facilities) quick tests on hygiene Laboratories Chemical residues in food of animal and plant origin • Commission staff working document on the understanding of certain provisions on flexibility provided in the hygiene package - Guidelines for the competent authorities Series of training on control and eradication of animal Regulators, inspectors, private sector, academia diseases (general and specific topics) Series of training on control and eradication of plant dis- • Commission Staff working document on the understanding of certain provisions on flexibility provided in the Regulators, inspectors, private sector, academia eases and pests (general and specific topics) Hygiene Package (Frequently Asked Questions – Guidelines for food business operators) Regulators, inspectors, private sector Animal welfare Regulators, inspectors, practicing veterinarians Animal identification and registration V. Guidance document on the implementation of certain provisions of Regulation (EC) No 853/2004 on the hygiene of food of animal origin Regulators, inspectors, practicing veterinarians Veterinary medicinal products Principles of application and control of pesticides and fertil- Regulators, inspectors, plant protection extension service izers VI. Guidance document on the implementation of procedures based on the HACCP principles, and facilitation of the implementation of the HACCP principles in certain food businesses National Residues Monitoring Program in animals, animal Laboratories, inspectors products and animal feed Accreditation of methods, certification of laboratories ac- Laboratories cording to ISO 17025 Regulators, inspectors, private sector WTO requirements – SPS and TBT Requirements for export of food – depending on the Inspectors, private sector market Private sectors, regulators, inspectors, retail sector Traceability 36 Investment Climate Food Safety Toolkit Annexes 4: Suggested list of topics to be covered by training and workshops 37 Annex 5: 3. Maintenance and sanitation • Use of suitable and tested products that are approved for use in food areas • Obtaining and labeling of equipment and objects for the different factory areas • Planning and implementing maintenance of equipment CheckLists • Drawing up of a cleaning and disinfection plan with information on: What? With what? How? When? How often? Who? • Storage of cleaning and disinfection products separately from foods The aim of checklists is to access the most important aspects of prerequisite programs Good Hygene Practices • Labeling of containers with disinfectants as protection against mistakes and Good Manufacturing Practices (GHP and GMP) in a structured way and to help identify potential places or • Separation of waste and labeling of the containers operations where hazards for safety of food occur. Once hazards are identified, their control or eradication is • Keep container closed, with lid enabled. • Have waste containers that can be opened with the foot Checklists should be used by inspectors to ensure the objectivity of their work. Also, they should be used by food • Store waste separately from hygienically clean work areas1 handlers to access the situation in their facility and to understand requirements set by inspectors. • Disposal conditions – store until collected (frequency) Checklists should cover the following issues: 4. Personal hygiene • Access regulations (for employees, visiting workmen, visitors) • Work clothing (jacket, trousers, head covering)2 • Gloves, mouth protection, beard cover • Prohibition of jewels (for example, wristwatch, chain, earrings, bracelet, bangles, visible piercing, rings) and mobile phones • Designation of places for eating, drinking, smoking aside from production areas • Avoidance of the spread of disease pathogens3 • Prohibition of certain activities and tasks in cases of illness • Hygienic treatment of infections on the hands • Regulations for “acute sic” or “permanent sources” of disease pathogens Good Hygiene Practice and Good Manufacturing Practice • Behavior in the event of illness • Reporting obligation in the event of signs of illness 1. Establishment design and facilities • Description of the factory site (fenced, wild, and domestic animals) • Visitors reporting of illness, rules of conducts • Surrounding area (countryside: woodland, lakes, river, agriculture), industrial area (such as chemical industry), city 5. Working with hazardous substances • Training employees in handling hazardous substances • Outside the factory building (for example, green areas ) • Labeling containers, such as for cleaning products and disinfectants, dissolvent • Hygiene status of the access routes (sandy pathways, soft pathways, muddy) • Observing the storage conditions • Separation of the hygiene zones into hygienically clean and non-clean areas • Keeping separate storage areas • Regulations governing flow of persons and materials • Actions in case of emergencies • Design of the work areas (rooms, walls, ceilings, windows, doors, loading-bay doors) 6. Packaging and labelling • Appropriate packaging for the type of products • Hygiene status of the plant, machines, apparatus, work surfaces • Fulfilment of labelling requirements (identification of product) • Pallets (for example, wood, plastic) • Hygiene in the non-production areas (receipt of goods area, stores) 7. Storage • Hygiene, light, ventilation, protection of pests • Wood, glass, plastic and other materials in production areas • Ensuring the required temperatures for the storage of semi-finished and finished prod- • Machines (appropriateness for the type of work, material from which they are made, ucts maintenance) • Storing raw materials and finished goods separately • Preventing direct contact with the floor and wall surface 2. Control of operation • Protection of the raw materials, inputs, packaging (including process materials) from contamination and cross-contamination (keep closed, short standing times, rotation) • Labelling opened containers • Adherence to the necessary temperatures and humidity (for example, cold chain) • Keeping rooms closed • Traceability of goods received and dispatched • Rotation of products (FiFo: first in-first out principle) • Handling rework • Respecting shelf life of products • Keeping surfaces that come into contact with the foods in hygienically flawless state • Following traceability procedures – controlling and recording lots of final products in the (without residues) storage and realized from the storage • Using interim storage areas • Recalled products visibly labeled and stored separately from products intended to the market • Separating clean and non-clean areas • Hygienic conditions for transport within the operation 8. Transportation • Fulfillment of special transport conditions • Hygiene of rooms, protection of pests • Adherence to hygienic loading procedures • hygiene of equipment and tools • Ensuring required transport temperatures • separate tools for separate processes • Using means of transport that are suitable for foods • organizing modern processing methods • Checking that vehicles are clean and vehicle surfaces have been cleaned • light conditions, ventilation and the number of micro-organisms in the air (if needed) • Observation of hygienic behavior on the part of the driver 38 Investment Climate Food Safety Toolkit Annexes 5: CheckLists 39 Food waste, inedible by-products and other waste: 1 Annex 6: • must be removed as soon as possible from areas in which foods are handled, so that accumulation of this List of food safety websites waste is avoided, and • must be stored in closable containers unless the company can prove to the relevant authority that other types 1. http://www.foodsafety.gov/ of container or other disposal systems are appropriate. These containers must be appropriately constructed, U.S. Government kept in perfect condition, be easy to clean, and if necessary, easy to disinfect. 2. http://www.usda.gov/wps/portal/usda/usdahome?navid=FOOD_SAFETY U.S. Department of Agriculture – Food Safety Persons who work in an area in which foods are handled must keep to a high standard of personal cleanliness. They 2 3. http://fsrio.nal.usda.gov/sanitation-and-quality-standards/legislation-and-regulations must wear suitable and clean work clothing, and if necessary, protective clothing. U.S. Department of Agriculture –Food Safety Legislation 4. http://www.fsis.usda.gov/ 3 Persons with a disease that can be transmitted through foods, or carriers of such a disease, and persons with infected U.S. Department of Agriculture – Food Safety and Inspection Service wounds, skin infections or lesions, or diarrhea are generally forbidden to handle foods or enter areas in which foods 5. http://www.fda.gov/AnimalVeterinary/default.htm are handled if there is the possibility of direct or indirect contamination. Such persons who work in a food company U.S. Food and Drug Administration – Animal & Veterinary and who may come into contact with foods must inform their employer without delay of illnesses and symptoms, 6. http://www.fda.gov/Food/default.htm U.S. Food and Drug Administration – Food and, if possible, their cause. 7. http://www.fda.gov/Food/FoodSafety/default.htm U.S. Food and Drug Administration – Food Safety 8. http://www.epa.gov/agriculture/tfsy.html U.S. Environmental Protection Agency – Food Safety 9. http://ec.europa.eu/dgs/health_consumer/index_en.htm European Commission Directorate General for Health and Consumers (DG SANCO) – Food 10. http://europa.eu/legislation_summaries/food_safety/index_en.htm EUROPA Summaries of EU legislation – Food Safety 11. http://www.efsa.europa.eu/ European Food Safety Authority 12. http://ec.europa.eu/health-eu/my_environment/food_safety/index_en.htm European Commission Health EU Portal – Food Safety 13. http://www.fao.org/food/food-safety-quality/en/ Food and Agriculture Organization (FAO) of the United Nations – Food Safety and Quality 14. http://www.who.int/foodsafety/en/ World Health Organization – Food Safety 15. http://www.who.int/foodsafety/codex/en/ World Health Organization – Food Safety – Codex Alimentarius 16. http://www.cdc.gov/foodsafety/ Centers for Disease Control and Prevention 17. http://foodrisk.org/rm/guidelines-and-standards/ Food Risk 18. http://www.eufic.org/article/en/expid/basics-food-safety/ European Food Information Council (EUFIC) – Food Safety 19. http://www.food.gov. uk/ U.K. Food Standards Agency 20. http://www.defra.gov.uk/ U.K. Department for Environment, Food and Rural Affairs 21. http://www.agriculture.gov.ie/ Irish Department of Agriculture, Food & the Marine 22. http://www.fsai.ie/links.html The Food Safety Authority of Ireland 23. http://www.inspection.gc.ca/eng/1297964599443/1297965645317 Canadian Food Inspection 24. http://www.hc-sc.gc.ca/fn-an/securit/index-eng.php Health Canada – Food Safety 25. http://agriculture.gouv.fr/ French Ministry of Agriculture, Food, Fisheries, Rural and Regional Development 40 Investment Climate Food Safety Toolkit Annexes 6: List of food safety websites 41 26. http://www.anses.fr/ Alimentation, Environment, Travail (ANSES); French Agency for Food, Environment, and Occupational Health and Safety Bibliography – further reading 27. http://www.fvm.dk/english.aspx?id=14541 Danish Ministry of Food, Agriculture and Fisheries 28. http://www.foedevarestyrelsen.dk/english/Food/Pages/default.aspx Danish Veterinary and Food Administration - Food 29. http://www.lebensministerium.at/lebensmittel.html Austrian Federal Ministry of Agriculture, Forestry, Environment and Water Management - Food Justification and scope 30. http://www.ages.at/ages/en/federal-office-of-food-safety/ 1. United Nations Austrian Federal Office of Food Safety http://www.ias.unu.edu/sub_page.aspx?catID=155&ddlID=154 http://www.health.belgium.be/eportal/foodsafety/index.htm 2. Food and Agriculture Organisation Belgian Federal Public Service for Health, Food Chain Safety and Environment – Food Safety http://www.fao.org/index_en.htm 31. http://www.favv-afsca.fgov.be/home-en/ 3. Global Food Safety Partnership Belgian Federal Agency for the Safety of the Food Chain (FASFC) http://fscf-ptin.apec.org/docs/final%20Global%20FS%20Partnership%20Brief%203%2029%202012.pdf 32. http://www.mmm.fi/en/index/frontpage/food_safety.html 4. International Food Safety Authorities Partnership Finish Ministry of Agriculture and Forestry – Food Safety and Consumer Information http://www.who.int/foodsafety/fs_management/infosan/en/ 33. http://www.evira.fi/portal/en/food/ 5. OIE Finnish Food Safety Authority (EVIRA) http://www.oie.int/ 34. http://www.bmelv.de/EN/Food/food_node.html 6. IPPC German Federal Ministry of Food, Agriculture and Consumer Protection – Food & Safety https://www.ippc.int/ 35. http://www.ble.de/EN/00_Home/homepage_node.html German Federal Office for Agriculture and Food Guiding Principles 36. http://www.minagric.gr/en/index.html 7. Global Food Safety Resource Hellenic Ministry of Agriculture and Food http://www.globalfoodsafetyresource.com/article/new-content/255-regulatory-affairsgovernment/811-canada- 37. http://www.efet.gr/ and-us-food-safety-reform.html Hellenic Food Safety Authority 8. Barriers to HACCP Implementation 38. http://www.sweden.gov.se/sb/d/11310 http://www.flavorfood.com.br/artigos/aplicacoes_haccp/Difficulties%20and%20barriers%20for%20the%20 Swedish Ministry of Rural Affairs – Foodstuffs implementing%20of%20HACCP%20and%20food%20safety%20sistems%20in%20food%20business%20 39. http://www.slv.se/en-gb/ in%20Turkey.pdf Swedish Food Safety Authority 9. The relationship of food safety standards 40. http://www.government.nl/issues/food-and-food-safety http://www.fao.org/docrep/016/ap236e/ap236e.pdf Ministry of Economic Affairs, agriculture and Innovation – Food and Food Safety 41. http://www.vwa.nl/english Legislative Reform Netherlands Food and Consumer Product Safety Authority 1. EFTA 42. http://www.regjeringen.no/en/dep/lmd.html?id=627 Norwegian Ministry of Agriculture and Food http://www.efta.int/ 43. http://www.regjeringen.no/en/dep/hod/About-the-Ministry/Subordinate-institutions/Norwegian-Food-Safety-Authority. 2. NAFTA html?id=279765 http://www.naftanow.org/ Norwegian Food Safety Authority 3. CEFTA 44. http://www.mcx.ru/ http://www.ceftatradeportal.com/ Russian Federal Ministry of Agriculture 4. EAC 45. http://www.maf.govt.nz/ http://www.eac.int/ New Zealand Ministry of Agriculture and Food 5. Perspectives and guidelines on food legislation, with a new model food law 46. http://www.foodsafety.govt.nz/ http://www.fao.org/fileadmin/user_upload/legal/docs/ls87-e.pdf New Zealand Food Safety Authority 6. Codex Sampling Guidelines 47. http://www.agric.wa.gov.au/PC_92635.html?s=1623242088,Topic=PC_92635 www.codexalimentarius.org/input/.../standards/10141/CXG_050e.pdf Australian Department of Agriculture and Food 48. http://www.foodstandards.gov.au/ Institutional Structure Food Standards Australia New Zealand - Bi-national Government Agency 7. Joint FAO/WHO PROPOSED DRAFT PRINCIPLES AND GUIDELINES FOR NATIONAL FOOD CONTROL SYSTEMS, 49. http://www.bfr.bund.de/en/food_safety-737.html ftp://ftp.fao.org/docrep/fao/009/a0601e/a0601e00.pdf German Federal Institute for Risk Assessment (BfR) 50. http://www.foodstandards.gov.au/foodstandards/foodstandardscode.cfm Food Safety Standards Australia New Zealand 51. http://ec.europa.eu/health-eu/my_environment/food_safety/index_en.htm European Commission website on Food Safety and Health 42 Investment Climate Food Safety Toolkit Bibliography 43 Risk Assessment 1. WHO/FAO 2008; Risk characterization of Microbiological Hazards in Food, Microbiological Risk Assessment Series 17, WHO/FAO 2009 Acronyms http://www.who.int/foodsafety/publications/micro/MRA17.pdf 2. WTO /SPS applicability http://centers.law.nyu.edu/jeanmonnet/archive/papers/04/040201.pdf APLAC Asia Pacific Accreditation cooperation HACCP Hazard Analysis Critical Control Point System 3. Preparing for effective enforcement BAP Best Aquaculture Practice ILAC International Laboratory Accreditation Cooperation http://www.oecd-ilibrary.org/sites/gov_glance-2011-en/10/03/index.html;jsessionid=us2jjljdwu7x. BRC British Retail Consortium KDB Kenya Dairy Board delta?contentType=&itemId=/content/chapter/gov_glance-2011-52-en&containerItemId=/content/ CAC Codex Alimentarius Commission KEBS Kenya Bureau of Standards serial/22214399&accessItemIds=/content/book/gov_glance-2011-en&mimeType=text/html CAS Country Assistance Strategy LIMS Laboratory Integrated Management System Principles of Food Safety Management CFIA Canadian Food Inspection Agency NGOs Nongovernmental organizations 1. HACCP CPS Country Partnership Strategy ILAC International Laboratory Accreditation Cooperation http://www.who.int/foodsafety/fs_management/haccp/en/ EAL European Cooperation for Accreditation of IPPC International Plant Protection Convention 2. Introducing HACCP Laboratories http://www.who.int/foodsafety/fs_management/haccp_intro/en/ OECD Organisation for Economic Co-operation and 3. Guidance on HACCP Implementation in small businesses EC European Commission Development ftp://ftp.fao.org/docrep/fao/009/a0799e/a0799e00.pdf EAC East African Community OIE World Organization for Animal Health 4. Codex HACCP EFSA European Food Safety Authority PCB Pest Control Products Board http://www.fao.org/docrep/W8088E/w8088e05.htm EU European Union PRPs Prerequisite Programs 5. Codex prerequisites www.codexalimentarius.org/input/download/.../23/CXP_001e.pdf FAO Food and Agricultural Organization RFID Radio frequency identifier FBO Food business operators SBA Sustainable Business Advisory GDP Goss Domestic Product SPS Sanitary and Phytosanitary GAP Good agricultural practices SQF Safe Quality Food GFSI Global Food Safety Initiative USAID U.S. Agency for International Development GHP Good hygiene practices USDA U.S. Department of Agriculture GMO Genetically modified organisms WHO World Health Organization GMP Good management practices WTO World Trade Organization GRMS Global Red Meat Standard 44 Bibliography Credits Photography: BigStockPhoto (cover page), Lilyana Vynogradova (page 10), Yue Lan (page 16), Mark Yuill (page 17) in partnership with: