Project Implemented by:Co-funded by:

www.eu-aseanforum.com

Rapporteur: Jorgen Schlundt,Nanyang TechnologicalUniversity, Singapore

ASEAN FOOD SAFETY DEVELOPMENTSHarmonization Towards a Single Market

WHITE PAPER 2015

EXECUTIVE SUMMARY

The ASEAN Community Vision 2025 aims to transform ASEAN into a highly competitive region and the future ASEAN Economic Community (AEC) creation offers the opportunity of a huge market of US$2.6 trillion and over 620 million consumers. ASEAN now also has active programmes related to food safety standards harmonization. This recent development towards a more unified market/economic development and food standards in ASEAN in some areas resemble the development in the European Union over the last 20 years. It is thus relevant for ASEAN programmes to look at EU experiences to consider its potential relevancy in SE Asia.

The EU-ASEAN Forum on Food Safety 2015 focused on key principles and practical implications of the harmonization of food safety standards in the ASEAN region. While existing agreements (e.g. the “Trade in Goods Agreement” (ATIGA)) already support harmonized food safety principles, ASEAN Member States (AMS) now support further harmonization. Thus the new ASEAN Food Safety Policy and the ASEAN Food Safety Regulatory Framework support new important initiatives, including the previously decided creation of the ASEAN Risk Assessment Centre for Food Safety(ARAC) and the ASEAN Rapid Alert System for Food and Feeds (ARASFF).

Recognizing these positive developments, and supporting the need for including international and regional experience in ASEAN deliberations, the Forum also listed a number of specific issues for further consideration, including:

- the need for food safety risk assessments of the full production chain- implications of the present segmentation of the food regulatory structure in AMS?- how to harmonize risk management and risk communication between AMS?- should responsibility for the safety of food reside with the food business operator?- the need for food safety capacity building for Small and Medium size Enterprises- will standards harmonization also mean ASEAN coordination of risk reduction?

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The event was officiated by His Excellency, The Minister of Health Malaysia, YB Datuk Seri Dr. S.Subramaniam and the Ambassador and Head of the EUDelegation, HE Luc Vandebon

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1. Introduction

The second, annual EU-ASEAN Forum on Food Safety was held in Kuala Lumpur, Malaysia, on the 8th-9th of December 2015. With the support of platinum sponsors DPO International and Novozymes Malaysia Sdn Bhd, the event was officiated by His Excellency, The Minister of Health Malaysia, YB Datuk Seri Dr. S.Subramaniam and the Ambassador and Head of the EU Delegation, HE Luc Vandebon. The Minister emphasized the AMS obligation to realize the ASEAN Economic Community by 2015 through various concerted efforts and future initiatives. DPO International’s Group CEO Daniel Pans gave the opening address for Day 2 of the event, speaking on the topic of ‘Harmonized Food Safety Standards as a solid business case for ASEAN’ while Novozymes’ Senior Science Manager of Regulatory Affairs, Peter Hvass spoke on ‘Contributions to Harmonization and Food Safety Initiatives from a Bio-innovative Leader’.

The forum was intended as a platform for food authorities and experts from ASEAN and Europe to present and discuss experiences, recognizing the role that ASEAN and EU play in each regions mutual growth and future sustainable developments. The specific background for the 2015 forum relates to a recognition of the importance of new developments in food standards harmonization as well as the potential to make use of the specific regional EU experience in this area.

1.1. Recent developments in food standards harmonization

Recent years have seen an increasing need for international alignment of regulatory policies and standards in a number of areas, with food trade and -safety being one of these areas.

An important new focus of food standards policy developments has been the novel paradigm moving towards standards and management decisions based on scientific risk assessments. A concurrent change toward considering the full food production chain in a holistic manner has also resulted in a need for data from the full production chain: from the live animal to the food factories to the kitchen. This new concept is now referred to internationally as ‘One Health’, but was already previously implemented in some regions under the umbrella term: ‘Farm to Table’. These types of data and estimations are also necessary to enable cost-effective solutions and safer food at the same time, which will both lead to a better and more sustainable economy in importing as well as in exporting countries.

While the internationalization of food trade and thereby the development of international food safety standards have received a boost from the increased globalization in recent decades, international food standards have in fact been-developed since the 1950’s, primarily though the FAO/WHO Food Standards Programme and its active arm: the Codex Alimentarius Commission. While this global (UN) system is inherently international in nature and thus presupposes participation of all countries (Codex presently has 186 Member States) until recently been an overweight of suggested standards from industrialized (OECD) countries. With a one-country-one-vote principle in Codex, EU countries do not possess increased influence in the decision process. But while each country still has a right to debate in Codex negotiations, EU countries mostly present a pre-agreed, harmonized position; often enabling strong influence in the deliberations as well as power to enable compromised solutions.

In addition to the (global) Codex system for international food standards development, a number of bi- and multi-lateral systems for standards harmonization already exists. At present, one of the most important such systems is the Transatlantic Trade and Investment Partnership (TTIP) between EU and the USA, a partnership by some considered to be a companion agreement to the Trans-Pacific Partnership (TPP). The negotiation of the TTIP Partnership (planned for finalization in 2016) includes consideration of technical barriers to trade and sanitary and phytosanitary measures, i.e. food and food-production related standards. It has been suggested that the TTIP partnership could lead to significant (bi-lateral) agreements influencing a standard setting for a very significant proportion of the global market, thus enabling EU influence. While a number of European countries are significant trading partners globally in their own right, it is clear that the US-EU Partnership would not have been in existence in this form without the European Union construction, especially the standards harmonization efforts in the EU relative to foods and food production.

The EU construction has thus enabled significant (most likely additional) influence of European EU Member States in relation to international food standards development originating from at least three factors:

i. A multi-country basis for compromised solutions in standards development

ii. A stronger voice in international (Codex) standard settings

iii. A stronger presence in important bilateral trade partnerships

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1.2. EU experience in food standards harmonization

The European Union is a further development from the European Economic Community (EEC), and was formally created by the Maastricht Treaty on November. 1993. It is a political and economic union between European countries, enabling the creation of EU policies concerning their members’ economies, societies and to some extent security. The EEC and the European Union (EU) were developed with a view of ensuring peace and constructing an open market for all products, including food. The economy in EU Member States has been helped by the fact that EU countries have stopped charging custom duties within the EU common market. One of the key pillars in EU development has been the agreement between Member States to exercise joint control over food production, including joint development of food standards in most food production areas, contributing significantly to a surplus agricultural production within the market as well as significant food export potential.

The generic basis for the harmonization of food standards within the EU was initiated through the principle of mutual recognition (everything that is accepted in one country, is accepted in all). Developing further from this, the EU food standards construction is now based on a combination of binding Laws (Regulations) and suggested directions (Directives). The key piece of legislation is Regulation (EC) 178/2002, finalized in 2002, which was completed in record time following the development of the ‘White Paper on Food Safety’ published in 2000, following a series of food safety scandals in the 1990’ies. It should be noted that Regulation (EC) 178/2002 also includes references to significant new food safety principles developed internationally in the 1990’s, notably the FAO/WHO ‘Application of Risk Analysis to Food Standards Issues’ from 1995, defining a suggested novel framework for food safety and food control based on scientific risk assessments and regulatory risk managements of food issues.

Food standards development within the EU over the last 15 years have thus provided important potential lessons for any international food standards harmonization effort between like-minded countries. The EU food standards experience could be used either as a stand-alone or in combination with national experience in the development and implementation of new food standards and food safety management systems from within or outside the EU.

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2. Scientific & strategic areas presented at the EU-ASEAN Forum on Food Safety 2015

The presentations at the EU-ASEAN Forum on Food Safety 2015 covered a broad scope of issues related to food production, food safety and regulatory action. Regulatory and industry professionals from both ASEAN and EU Member States participated in the deliberations, contributing to an interesting and lively exchange of ideas as well as suggestions for further development.

2.1 Experiences from 50 Years of EU Food Law

A significant number of novel suggestions for the revision of the EU Food Safety system were put forward in the EU ‘White Paper on Food Safety’ published in 2000. Among these, was the creation of EFSA (European Food Safety Authority), aimed at providing independent food safety risk assessments to be used by the EU Commission when managing risk and developing standards. Additionally, it was suggested that the FVO (Food and Veterinary Office) to be created to inspect if EU legislation on food safety, animal health, etc. is properly implemented and enforced. Legislative reforms were also recommended, specifically the creation of new Food Regulation, and the simplification of existing systems, along with new crisis management and emergency procedures that would strengthen the Rapid Alert System for Food and Feed (RASFF).

Following the White paper, specific regulations were completed in record time: REGULATION (EC) No 178/2002 outlined a coherent and comprehensive approach, including a number of key principles:

- Traceability 'from farm to fork' (for food & feed)- Functional separation between risk assessment and risk management- Risk assessment based on best available/independent science- Risk management based on risk assessment and precautionary principles- Transparency, stakeholder consultation, including open access to information

This regulation also provided a new legal framework for food business operators with clearly assigned responsibilities where producers, distributors, and retailers each have a share of the responsibility for the safety of the final product, with regulatory officials responsible for controls. Another important principle demanded equal treatment of domestic producers and importers from non-EU countries. Finally, the regulations also included a new emphasis on international

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obligations, including obligations to take international standards into account (Codex, OIE, IPPC), to contribute to development of international standards and to take into account the situation of developing countries.

In addition to these developments, the following characteristics might support the use of EU experience as a model for regional integration in relation to food standards and harmonization.: EU represents a multi-country, diverse political system, multi-cultural and is multi-lingual in nature. The EU regulatory model supports free trade, a high level of food safety and consumer protection, contributing to food security as well as nutrition. The EU system is built around a single agency model with a functional separation between risk assessment andrisk management based on a holistic (One Health) approach with traceability from farm to table.

It should be noted that not all areas related to Food and Food production are harmonized in the EU. An interesting example of non-harmonization presented at the meeting relates to regulatory requirements for food enzymes. At present, enzymes in food production is regulated in EU Member States through three different regimes: a) Approval of each product, b) Positive list, c) No restrictions. The EU and EU Member States have now taken steps through the Food Improvement Agents Package (FIAP) to create a harmonized regulatory system for food enzymes across the European Union. FIAP first came into force in 2009, but is only expected to be fully implemented in 2021.

2.2 Existing ASEAN Sectoral Bodies involved in theHarmonization of Food Safety Standards in ASEAN

The current, formalized basis for food safety standards harmonization (or any other traded goods standards harmonization) within ASEAN is the “Trade in Goods Agreement” (ATIGA). Clearly referring to the WTO/SPS Agreement Article40.1 in ATIGA states: “Each Member State shall not adopt or maintain any non-tariff measure on the importation of any goods of any other Member State or on the exportation of any goods destined for the territory of any other Member State except in accordance with its WTO rights and obligations or in accordance with this Agreement” while Article 81.3 states: “Each Member State commits to apply the principles of the SPS Agreement in the development, application or recognition of any sanitary or phytosanitary measures with the intent to facilitate trade between and among Member States while protecting human, animal or plant life or health in each Member State.”

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2.2.1 ASEAN Consultative Committee for Standard and Quality-Prepared Foodstuff Product Working Group

Specifically relative to food safety standards, the ASEAN Consultative Committee for Standard and Quality-Prepared Foodstuff Product Working Group (ACCSQ-PFPWG) has already prepared and endorsed a number of harmonized technical requirements, known as the ASEAN Common Food Control Requirements (ACFCRs), which includes:

The adoption of the newly developed ACFCRs is a significant step towards harmonisation of food control systems in ASEAN. When such requirements are implemented by AMS, they will provide the basis for mutual recognition between AMS. The implementation of the ACFCRs will also ensure that Member States food control systems are based on internationally accepted principles and practices. In addition, Guidelines on establishing limits for Food Contaminants are also under development.

On the laboratory front, a network of ASEAN Food Testing Reference Laboratories is currently under establishment. At present stage, six laboratories have already been identified, and work is ongoing to initiate proficiency testing and laboratory training in the region.

2.2.2 ASEAN Expert Group on Food Safety

The ASEAN Expert Group on Food Safety (AEGFS) under the ASEAN Health Ministers Meeting provides assistance to AMS in developing and strengthening food safety infrastructures and programmes which support them in dealing with the new obligations and rights related to the safety and quality of food in both regional and international trade. AEGFS has developed ASEAN Food Safety Improvement Plan (AFSIP) covering activities in a number of areas, with strategies

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ASEAN Principles and Guidelines for National Food Control Systems (CAC/GL82 MOD)ASEAN General Principles of Food Hygiene (CAC/RCP 1 - 1969, Rev.4 MOD)ASEAN Principles for Food Import and Export Insp. and Certification (CAC/GL20 MOD)ASEAN Guidelines for the Design, Operation, Assessment and Accreditation ofFood Import and Export Inspection and Certification Systems (CAC/GL 26 MOD)ASEAN Guidelines for Food Import Control Systems (CAC/GL 47 MOD)Guidelines on Inspection and Certification of Food Hygiene

AFSIP also maintains a focus on seven specific areas: Legislation, Laboratories, Monitoring and surveillance, Food safety systems, Food inspection and certification, Information sharing and Consumer participation and empowerment.

2.3 ASEAN future cooperation on Food Safety policy and EU support for ASEAN food safety integration

Present developments notwithstanding, ASEAN Member States (AMS) clearly want to further develop food standards harmonization.

The ASEAN Community Vision 2025, launched during the ASEAN Summit, Nov. 2015, aims to transform ASEAN into a stable, prosperous, and highly competitive region with equitable economic development, and reduced poverty and socio-economic disparities. The future ASEAN Economic Community (AEC) creation represents a major milestone in the regional economic integration agenda in ASEAN, offering opportunities of a huge market of US$2.6 trillion, with over 622 million consumers, positioning AEC as the third largest economy in Asia and the seventh largest in the world.

As part of this overall drive towards market development (and health promotion) ASEAN has active programmes related to food safety in three sectors under the Health, Agriculture and Economic Ministers. While considerable work has been done in each group, linkages between the sectors are still weak in ASEAN, as indeed such linkages are in most countries and regions globally.

ARISE (ASEAN Regional Integration Support from the EU) was invited to provide support in the development of the ASEAN Food Safety Regulatory Framework. As part of this process, an ASEAN Food Safety Policy has been developed and endorsed by the Health Agriculture and Economic Minister. The Product Working Group on Prepared Foodstuffs (PFPWG) has been designated the lead body for the preparation of the ASEAN Food Safety Policy and the ASEAN Food Safety Regulatory Framework.

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on the following:

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Strengthening the coordination of ASEAN food bodies/subsidiaries and theimplementation of their work programmes

Capacity Building on Risk Assessment

The ASEAN Food Safety Policy has been drawn up considering relevant international texts, notably the FAO/WHO and Codex documents on Food Safety Risk Analysis Principles, and the Policy is thus consistent with WTO/SPS (Sanitary and Phytosanitary) and WTO/TBT (Technical Barriers to Trade) Agreements. The Policy provides a common, agreed reference for a coordinated approach to food safety in ASEAN, applicable to all sectors, and consists of 10 core principles:

1) Integrated 'Food Chain' Approach 2) Systematic Risk Analysis Framework 3) Science-based, independent risk assessment process. 4) Primary Responsibility of Food Business Operators5) Consistency with ATIGA and WTO’s SPS and TBT Agreements 6) Equivalence and Mutual Recognition7) Harmonisation with International standards 8) Reliable Traceability System 9) Strengthening and harmonisation of regional/national food control systems 10) Transparency

The Development of the ASEAN Food Safety Policy should be seen as one step in enabling the development of an integrated regulatory framework for food safety in ASEAN. This will in turn provide the basis for furthering the development and implementation of harmonised requirements and recognition initiatives that aims to achieve the twin targets of removing technical trade barriers effectively in the food sector and enhancing food safety for the people in ASEAN. The establishment of an agreed food safety policy in ASEAN could also provide a basis for food safety legislation in AMS that would regulate the safety of food throughout the stages of primary production, processing, storage and distribution of food products within the ASEAN region in a harmonised manner.

Although the Policy is recent, several tangible initiatives have been achieved that could fit under the Policy umbrella. Specifically relative to Principles 2 and 3, the formal creation of two ASEAN constructions should be noted: The ASEAN Risk Assessment Centre for Food safety (ARAC) and the ASEAN Rapid Alert System for Food and Feed (ARASFF); these two initiatives are now hosted in Malaysia and Thailand respectively.

The creation of ARAC originates with the aforementioned ASEAN Expert Group on Food Safety (AEGFS) under the ASEAN Health Ministers Meeting. ARAC has been created to provide independent scientific opinions on food safety issues of common interest in ASEAN (including during food safety crises) and to promote adoption of common positions and food safety measures that promotes health

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and facilitates trade. The specific objectives of ARAC are:

- Coordinate the implementation of food safety risk assessment in ASEAN- Strengthen the capacity of AMS in Risk Assessment - Facilitate the sharing of information and experiences on risk assessment- Provide a pool of qualified experts for risk assessment - Coordinate and communicate with relevant ASEAN Sectoral Bodies and key development partners

In addition to the development of the ASEAN Food Safety Policy a study has been undertaken to take stock of the existing legislation, institutions and initiatives in food safety in ASEAN at national levels. The findings will be evaluated to develop options to propose a regional regulatory framework on food safety in ASEAN. A roadmap identifying the actions required to implement the ASEAN Food Safety Regulatory Framework will be proposed after the ASEAN Member States (AMS) reaches a consensus on the Framework.

2.4 Stakeholders involvement and Industry’s support in food safety standards harmonization in ASEAN

As it has been emphasized internationally as well as in most new food safety (national or regional) policy documents, it is very important to involve stakeholders (including industry, consumers and academia) in food safety and food standards development. While stakeholders have a role in supporting standards development, consumer NGOs, scientific organizations and industry stakeholders in different regions have also taken up the responsibility of supporting the development of the scientific background for standards development as well as the training efforts relative to new food safety principles and tools. One of the most important new tools is science-based risk assessment. For both microbiological but especially chemical risk assessment and exposure assessment, an important - often missing– group of essential data is data about food consumption. Such data necessarily must come from national or regional food consumption and/or nutrition surveys. To that end, the International Life Sciences Institute (ILSI) Southeast Asia Region, which is a scientific non-profit organization, has organized two ASEAN Food Consumption Data & Exposure Assessment Workshops and a follow-up initiation of an ASEAN Food Consumption Database, originally requested by the AEGFS and supported by FAO, WHO. In a broader more general initiative, ILSI Southeast Asia Region has since 2001 organized a total of 11 workshops as part of a series on ASEAN Food Safety Standards Harmonization. This initiative also

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included the creation of the ASEAN Food Safety Standards Database compiling information on food additive standards from all 10 AMS according to food cate-gorization based on the Codex Alimentarius General Standard for Food Addi-tives.

The importance of both public and private engagement in developing standards harmonization is generally recognized in ASEAN, including amongst stakeholders. Thus both national (e.g. Malaysian Food Manufacturing Group, Indonesian Food & Beverage Association) and regional (e.g. ASEAN Food and Beverage Alliance) Industry organizations are stepping up their efforts in support of standards harmonization through active participation, capacity building efforts and the construction of alliances across sectors and national borders.

The interest of the food industry in employing efficient (and harmonized) standards in the food production process is not only altruistic. It is realized that a reflection of consumers' satisfaction is their continuing purchase of the same products. Food manufacturers and marketers thus have an investment in their product identities (brand names) that they naturally wish to protect. It is in their interest, therefore, to establish and administer the controls that ensures their products do indeed meet consumer expectations of safety and quality. In addition, it is estimated that food withdrawals, rejections and recalls on a global scale cost the food industry $7 billion dollars annually. Thus it is understood that it makes good sense that in relation to health, brand, economy and – more recently – to Corporate Social Responsibility (CSR) to develop, implement and enforce harmonized standards.

The general responsibility of the producer has also been realized amongst food industries in the ASEAN region. While consumers, governments and others play an important part in ensuring food safety and quality, in free-market societies, the ultimate responsibility for investing the physical and managerial resources that are necessary for implementing appropriate controls lies with the food industry - the industry that continuously oversees the manufacture and processing of foods, from raw ingredients to finished product, day in and day out.

It should be noted that in ASEAN – as indeed in most other regions – there are specific issues to be tackled relative to Small and Medium-sized Enterprises (SMEs). To compete in a regional and especially a global market, SMEs in ASEAN have several impediments: most SMEs do not have a legal identity, have not reached industrial scale (limited resources, area, etc) and suffer from a lack of knowledge of food processes and innovation and of food safety in general.

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Efforts should be made to support SMEs in at least the following areas:

- Provision of legal identity - Mentoring, e.g. CSR based on a business approach (not "charity”)- Assistance in technology & innovation, including the upholding of standards- Aiding in obtaining market access

3. Important areas in need of further strengthening in support of ASEAN food safety standards harmonization

Based on the comprehensive background presented at the meeting, an engaged and informed debate between ASEAN Member State Regulators combined with direct interaction with the audience followed. This created an opportunity to elucidate issues important for further food safety policy development in ASEAN.

The outcome of these discussions, as well as a description of issues raised is presented in the next pages, separated in the following key areas:

- Relevancy of experience from EU for the ASEAN situation- Status of the ASEAN food safety standards harmonization efforts- Issues identified needing further attention

3.1. Relevancy of experience from EU for the ASEAN situation

The European Union (EU) comprises 28 member states, all party to the founding treaties of the union and thereby subject to the privileges and obligations of membership. Unlike members of most international organisations, the member states of the EU are subject to binding laws in exchange for representation within the common legislative and judicial institutions. This means that every action taken by the EU is founded on treaties that have been approved by all EU member states. For example, if a policy area is not cited in a treaty, the EU Commission cannot propose a law in that area. A treaty is a binding agreement between EU member states. It sets out EU objectives, rules for EU institutions, how decisions are made and the relationship between the EU and its member states. Under the treaties, EU institutions can adopt legislation, which the member states then implement. This legislation includes binding Laws (Regulations) and suggested directions (Directives). The key piece of legislation in the Food area is Regulation (EC) 178/2002, finalized in 2002, thus outlining action areas where EU Member States will have to follow the EU regulatory framework.

The ASEAN Community Vision 2025 outlines a future ASEAN Economic Community construction by 2025 as being “highly integrated and cohesive; competitive, innovative and dynamic; with enhanced connectivity and sectoral cooperation; and a more resilient, inclusive, and people-oriented, people-centred community, integrated with the global economy.” This construction, however, does not base itself upon a Treaty, in the sense of the word applied by the EU. Therefore, harmonization efforts – including harmonization efforts in the food standards area – are not fully comparable between the EU and the ASEAN communities, and it is unlikely that this situation will change in the near-future.

This does not mean that EU experience – even legislative experience – cannot be of value in ASEAN. It is clear that both national and regional systems outside the EU can (and already do) benefit from EU regulatory and other constructions and experiences. It would seem clear that a number of important areas for ASEAN where experience or constructions could be lifted from EU experience are (non-restrictive list): - Risk management / Risk assessment separationThe Risk Analysis principles developed by FAO/WHO in 1995 , defines the need for a functional separation of scientific risk assessment and regulatory risk management of food issues; this separation has been fully implemented in the EU, with EFSA responsible for risk assessment and the EU Commission responsible for risk management.

- Independent, common risk assessment body (EFSA – ARAC)The European Food Safety Authority (EFSA) is a European agency funded by the European Union that operates independently of the European executive institutions (Commission, Council, Parliament) and EU Member States. EFSA was set up in 2002 to be a source of scientific advice and communication on risks associated with the food chain. The risk assessment work of EFSA is built upon risk assessment science and data from EU Member States as well as the scientific world in general, and is provided by selected, independent experts from either EU Member States or from the scientific world outside the EU. The recent construction of ARAC has already included significant EFSA experience.

- Mutual recognition Mutual recognition rules as applied in the EU ensures market access for products that are not subject to EU harmonisation. It guarantees that any product lawfully sold in one EU country can be sold in another, even if the product does not fully comply with the technical rules of the other country. EU regulation also defines

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how a country can deny mutual recognition of a product. A Mutual Recognition Agreement (MRA) is already being drafted in ASEAN for prepared foodstuffs (see section 2.2.)

- Emergency information exchange structure (RASFF – ARASFF)Created in 1979 the EU Rapid Alert System for Food and Feeds (RASFF) enables food and feed emergency information to be shared efficiently between its members and ensures the transmission of urgent notifications. Such information can lead to products being recalled from the market, in the EU and beyond. EU RASFF collaborates with the global emergency system WHO INFOSAN (International Food Safety Authorities Network). ASEAN RASFF was created in 2014 and is a mirror system of EU RASFF, presently hosted in Thailand.

- Farm to table principles The EU integrated (Farm-to-Table) approach to food safety aims to assure a high level of food safety, animal health, animal welfare and plant health within the EU through coherent measures and adequate monitoring, while ensuring the effective functioning of the internal market. Measures (risk management) are decided by the EU Commission, often in collaboration with Member States, as is the gathering of relevant data. In enabling this system, the risk manager interacts with, and seeks information from the risk assessor (EFSA).

While considering a list of specific, relevant EU food policy and food standards experience, it is important to also consider the inclusion of experience from nation states, including states within or outside EU.

3.2. Status of the ASEAN food safety standards harmonization efforts

The accelerated ASEAN integration/harmonization in food trade will most likely result in significant economic development, from both inter-ASEAN trade and export to third countries. It is thus important to develop relevant quantitative indicators as well as to communicate the development as close to real-time as possible.

The development of an ASEAN Food Safety Policy is an important step providing an agreed common reference for a coordinated approach. This Policy will form the basis for the development of the ASEAN Food Safety Regulatory Framework.

There is clear political support to move in the direction of further coordination and harmonization. Creation of specific (new) entities for coordinated ASEAN

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action is a positive signal towards harmonization (e.g. ARAC and ARASFF).

ASEAN Member States already coordinate efforts in relation to the development of International standards (notably in the FAO/WHO Codex Alimentarius Commission) and in relation to meeting (mutually recognized) standards with trading partners (e.g. USA and EU).

There are presently several ASEAN Working Groups, Sectoral Working Groups, Task Forces, Expert Groups, Consultative Groups and Fora with Terms of Reference related to food safety and standards harmonization. It will be important to share commonalities in priority/focus areas for coordination of efforts (i.e. standards, conformity assessment procedures, etc.). This is an area which may be unfolded in the Strategic Plan of Action for the next 5 years.

Likewise, the increased focus – and activities - in the food area in general will result in an increased need to develop monitoring and evaluating mechanisms for the implementation of harmonized standards and food initiatives under ASEAN. In this regard the previously mentioned study (Section 2.3.) that has been undertaken to take stock of the existing national legislation, institutions and initiatives in food safety within ASEAN could be considered as a basis for recurring analyses in this area.

3.3. Issues and Questions identified in need of further attention

The following list of questions reflect the considerations of ASEAN regulators and stakeholders at the present stage of ASEAN harmonization efforts (December, 2015). While ASEAN activities in the food safety area are longstanding and recently have been accelerated, some level of deliberation of these questions between AMS and within ASEAN bodies, could enable a more efficient preparation and implementation process in support of ASEAN food safety harmonization.

Regulatory structures and the pace of harmonization

In the absence of a binding ASEAN regulatory framework for food safety in the near future, would a more formalized system of Mutual Recognition Agreements represent the least complicated, but still efficient, alternative?

Mutual recognition rules in the EU preceded the binding regulatory framework in the food area, and thus can be said to represent the starting point of EU harmonization in this area. In effect, such recognition guarantees that any product lawfully sold

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in one EU country can be sold in another, even if the product does not fully comply with the technical rules of the other country. A Mutual Recognition Agreement (MRA) is already being drafted in ASEAN for prepared foodstuffs, with the aim to enable mutual recognition of food inspection and certification systems. When MRA requirements are implemented by AMS, they will provide the basis for mutual recognition between AMS, which supposedly will represent significant development towards foods standards harmonization.

Will the segmentation of an AMS regulatory structure continue in a novel ASEAN structure and how will that affect harmonization potential?

In many ASEAN countries, a system with different agencies and authorities with partial responsibility of the food production chain results in difficulty when attempting even national harmonization. Such issues have been recognized in EU Member States, as well as in the EU system itself before 2002. Significant improvement in efficiency and effectiveness of food safety regulatory action has followed from the introduction of a one-agency framework in the EU as well as in a number of significant EU Member States.

Further development at AMS and at ASEAN levels in order to enable structural-change, if deemed necessary, will most likely require significant effort in AMS, and concern has been expressed of whether sufficient capacity is allocated nationally to achieve relevant change, and to prepare efficiently for the harmonization process.

Will a sequential focus for harmonization efforts be considered (e.g. could the nature of different areas warrant a difference in the pace of harmonization)?

Such areas could for example be:- Common structures of control systems across AMS.- Common (uniform) systems for premarket approval in AMS.- Common interaction with international standard setting bodies between AMS.

The application of endorsed, harmonised technical requirements and other documents that are under development could be considered within a sequentially segmented process forward.

Will the primary responsibility for the safety of the food produced reside with the food business operator?

In traditional food control systems, the responsibility for the safety of food produced was often separated between several entities, including regulators, primary producers and retailers. It has since been recognized that when many

are given responsibility, often nobody takes it, but it has also been accepted that the ultimate responsibility for investing the resources necessary for appropriate controls lies best with the food industry – the food business operator - the enter-prises that continuously oversees the manufacture and processing of foods, from raw ingredients to finished product, day in and day out. Thus, the responsibility should lie with the person that puts the food on the market. This is now engrained in international principles as well as in national (e.g. USA) and regional (e.g. EU) legislation. Will a similar change take place in ASEAN and could the harmonization process be a logical driver for such change? Concentrating responsibility does not mean that everyone else looses a role: it will thus be important to deliberate on systems to integrate consideration of Role of government, Role of business and Role of consumer in achieving efficient food safety outcomes.

Risk assessment and risk management

Will ASEAN risk assessments be farm-to-table or only focused on ‘prepared food’, and how will scientific experts covering all sectors be included in the work?

The PFPWG has been designated the lead body for the development of the ASEAN Food Safety Policy. The MRA for Inspection and Certification Systems on Food Hygiene for Prepared Foodstuff Products is already being drafted.

Notably, international bodies, including FAO/WHO, OECD and the EU has put significant focus on the necessary cross-sectoral nature of ‘farm-to-table’ risk assessment as the basis for holistic and efficient risk management and regulatory action. To this end, the possibility to use industry data from the full chain in governmental risk assessment work could be considered, ensuring confidentiality of data as necessary.

Within the ARAC construction, it will be important to enable expertise covering all sectors of the ‘farm-to-table’ continuum, in support of One Health principles, but also in order to enable a full consideration of where the most efficient risk management option may lie – experience from the EU as well as other regions suggest that action at the source (which is sometimes at the farm) in certain cases can be both most cost-efficient and most effective. It will also be important to consider a possibility of including expertise from outside the region in the work of ARAC expert groups.

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Who will be the risk manager to ARAC’s risk assessor? And who will communicate about risk and emergencies?

An important pre-requisite for sensible risk assessments is clearly defined requests, typically through a risk assessment commissioning process. Such specific requests should come in the form of risk assessments questions, including a defined risk assessment policy, as defined by the risk manager. In this case, the risk manager/requesting body can be any AMS or any ASEAN Sectoral Working Group e.g the PFPWG. The risk manager may request the Risk Assessment to be conducted by ARAC, through the AEGFS. This request will be guided by procedures that had been developed by AMS for the use of the relevant ASEAN Sectoral Working Group.

In the event that AMS will be (combined) risk managers in this role, it will be important to define a cross-cutting forum for the Member States to achieve some level of coordination in the formulation of risk assessment questions. In addition, the role and management structure of ARAC needs deliberation and communication, including a clear description of how national risk assessment entities (Institutes, Universities, etc.) will interact with ARAC. It should be noted that in the US as well as in the EU system, risk assessment expertise is sought outside the risk assessment body. Thus, in the EU the real risk assessors primarily reside outside EFSA, participating as independent experts in EFSA Expert Groups and Panels (which include, as stated, experts from outside the EU). Experience from EU/EFSA also shows the importance of creating a cross-cutting forum for the Member States to achieve some level of coordination in risk assessment work in Member States and in EFSA.

Harmonized risk communication, including emergency communication can be very important – how will the ASEAN food safety initiatives provide such communication?

ASEAN Member States (AMS) could utilize the ASEAN Food Safety Network (http://www.aseanfoodsafetynetwork.net/) as a platform to communicate food safety risks to different stakeholders, including the general public, across the ASEAN Community. This may include sharing the outcomes of risk assessments undertaken by ARAC on a particular food safety issue of general concern. Each AMS should also aim to raise awareness about the existence of the ASEAN Food Safety Network among all stakeholders in order to facilitate this communication objective. It should be noted that, although some EU Member States refer to EFSA statements in emergency situations, most EU Member States still publish their own risk communication in such cases, typically referring to the necessity for the communication to take into consideration local/national situations that might not be included in more generic EFSA statements.

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Will consumers be involved in ASEAN food safety deliberations?

According to international principles, consumers should be considered important stakeholders in the Risk Analysis framework. Principle 10 of the ASEAN Food Safety Policy highlights that ASEAN Member States should make every effort to ensure effective communication with all stakeholders, including consumers, food business operators and other stakeholders at national and regional levels. Food business operators, consumers and other stakeholders should be informed of the rationale for introducing new food safety measures and be invited to contribute to the decision-making process.

Within the EU system, consumer - and industry - representatives have been included in the EFSA Management Board, and EFSA has held a significant number of stakeholder events (and hosts a stakeholder consultative platform) with participation of consumer and industry representatives.

Risk reduction

Will standards harmonization also mean coordination of risk reduction and estimation of foodborne disease burden in ASEAN?

The ultimate aim of food safety regulation is the avoidance of foodborne disease. Since the burden of foodborne disease is significant (in ASEAN as well as in all other parts of the world), this in turn translates into a necessity for countries to find ways to reduce the level of foodborne disease risk. It is likely that different AMS will have different priorities to this end, as has been seen also in EU, where different Member States focus different levels of effort on reducing different foodborne risks. One important new, presently research-heavy, standardized estimation of disease risk is the evaluation of foodborne disease burden for different (both chemical and microbiological) hazards. Do ASEAN countries have – or will they seek - good estimates of foodborne disease burden in order to enable a) sensible prioritization, and b) reasonable estimation of effect of risk mitigation efforts?

Will there be a system for efficient exchange of emergency information in the food area?

ARASFF does already exist, but is not optimally used – AMS need to consider how to use this tool efficiently. To this end it also needs to be considered whether there is a need to introduce some level of obligatory reporting of food safety incidents and food contamination events.

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Innovation and capacity building

Will there be scope – and funding – for SME capacity building efforts?

Recognizing that a very significant part of the food producers in the ASEAN region are SMEs and that SMEs typically find difficulties living up to new documentation and standardization regimes, there is likely a need for specific support in this area. It should be noted that Principle 4 of the ASEAN Food Safety Policy states that special consideration should be given to small and medium-size enterprises (SMEs) by the regulatory authorities to enable them to upgrade their food safety assurance systems that take into account their conditions. ASEAN Member States shall ensure that continuous and appropriate support and assistance is provided so that SMEs can meet national food safety requirements. It could be considered whether further deliberation is needed at national (and maybe also at ASEAN) levels about how to implement support structures with a special focus on SME capacity building relative to novel regulatory initiatives.

Future Innovation and sustainability

How will the ASEAN and AMS regulatory systems enable innovation in food production, introduction of new methodology and new technology, including new food production systems and novel utilization of side-stream efficiency in many food production sectors?

There will be an increased future need for assessment and improvement of the sustainability of food production systems, with a possibility to develop or combine science-based risk and sustainability assessments. In order to reduce the effect of an un-even playing field in regulatory support for innovative solutions, there is experience within the EU available such as experience in the construction of the EU FIAP (Food Improvement Agents Package) system for enzyme in food regulations.

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SPEAKERS & PANELLISTS

Speakers and Panellists at the EU-ASEAN Forum on Food Safety 2015 included food safety experts, decision makers and thought leaders the Academia, Regulatory and Operations sectors.

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Mr. Paul Mandl Team LeaderASEAN Regional Integration Support by the EU (ARISE)

Mr. Paul Mandl is currently Team Leader of the ASEAN Regional Integration Support from the EU (ARISE) programme, which is a technical co-operation facility with the purpose to support the implementation of key ASEAN

regional integration initiatives. During the past 20 years, Paul has worked in business development as well as managed complex Technical Cooperation Projects with a focus on trade, economic development, regional integration, economic policy dialogue and trade facilitation. He was the Director of ASEAN-EU Programme for Regional Integration Support (APRIS) II from 2009 to 2011 and the Director of the Centre for Trade and Regional Integration from 2007 to 2012. Prior to this he worked in the private sector notably Unilever in the food and agribusiness sectors.

Paul holds a Master’s degree in Agricultural Economics for Developing Countries from University of London and a Post Graduate Diploma in Development Economics from the University of East Anglia.

Professor Jørgen Schlundt ModeratorNanyang Technological University, Singapore

Jørgen Schlundt (JS) is currently a professor under the School of Chemical and Biomedical Engineering at the Nanyang Technological University in Singapore. Formerly, JS was also a Director for the Food Safety and Zoonoses

Department in WHO and the National Food Institute in the Technical University of Denmark.

He has also conducted vital work in the areas of risk assessment and decision support, related to environmental protection and food safety in Denmark, including 3 years in Zimbabwe. In this period he participated in the crucial standardization of microbiological and GMO risk assessment in Denmark and internationally.

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Mr. Raj Rajinder Sud Standards and Conformance ExpertASEAN Regional Integration Support by the EU (ARISE)

Mr. Raj Rajinder Sud has more than 20 years of practicalexperience in standardisation and quality & conformityassessment, acquired mainly in the ASEAN region. He also has direct experience in global trade matters through

his participation in TBT committees, bilateral trade negotiations, and the Asia-Pacific Economic Cooperation (APEC), as well as in the ACCSQ as the national representative of Malaysia (1994-2006). Mr. Sud has occupied senior level management positions at SIRIM and National Standards and Accreditation Body of Malaysia for over 14 years.

Dr. Siti Noorbaiyah Abd Malek PresidentMalaysian Institute of Food Technology, Malaysia

Dr Siti Noorbaiyah Abd Malek serves a dual role in FoodIndustry Asia (FIA), as Head of Scientific & Regulatory Affairs and Director to the ASEAN Food & Beverage Alliance (AFBA). She has more than 20 years training and

consultancy experience, first as an academician and later as a continuous professional development trainer for the food industry and government personnel in Malaysia. Her forte is in Food Safety and Quality courses like GMP, HACCP, Shelf-life, Food Packaging, and Halal certification. Dr Siti also sits in several committees in the Malaysian Ministry of Health, such as the Codex Working Committee in Food Contaminants and Food Additives. She is also the current President of the Malaysian Institute of Food Technology (MIFT), a professional body for the Food Science & Technology profession in Malaysia.

Mr. Ng Kim Keat Federation of Malaysian ManufacturersFMM Malaysia

Ng Kim Keat is currently the Scientific and Regulatory Affairs Director for Asia at The Coca-Cola Company. He provides scientific & regulatory leadership and stewardship to the Asia Pacific Group. He represents The Coca-Cola

Company as member of the Scientific & Technical Committee (STC) of Food Industry Asia (FIA) and currently serves as Deputy Chairman of STC. Kim Keat hold a Masters in Food Science & Nutrition and has over 20 years of experience in the field of scientific and regulatory affairs. He led the regulatory function for Kellogg's South East Asia before joining Nestle in 2001.

Ms. Viengxay Vansilalom DirectorFood and Drug Department (FDD), Ministry of Health

Ms. Viengxay Vansilalom is Director, Food Control Division of the Food and Drug Department (FDD), Ministry of Health, Lao PDR. Her responsibilities include food safety legislation development, food businesses registration,

and food safety quality assurance system promotion. Ms. Vansilalom is also the secretariat of the Codex Contact Point, Lao National Codex Committee, and a member of the ASEAN Consultative Committee on Standards & Quality (ACCSQ) Prepared Food Stuff Working Group, Vice Chair of the ASEAN Harmonization Standard Working Group, and Chair of the Technical Working Group of Agriculture and Food Standards. Ms. Vansilalom has organized a series of trainings, workshops and meetings in Lao in cooperation with the Food and Agriculture Organization of the United Nations (FAO), on topics such as HACCP, GMP, risk analysis, and sanitary and phytosanitary (SPS) measures. She obtained her Master of Food Chemistry in Russia and graduate qualification in Food Safety Quality Assurance in Germany.

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Mr. Adhi S. Lukman ChairmanIndonesia Food & Beverage Association (GAPMMI)

Recognized internationally as an authority on the food industry, Adhi Lukman is the current Chairman of GAPMMI, the Indonesian Food & Beverages Association. In 2015, he was elected as Deputy President for AFBA

(ASEAN Food and Beverage Alliance). In addition to his role with GAPMMI, Adhi Lukman works with several organizations, as Chairman of Permanent Committee for Development of Primary Agricultural Industry, Indonesian Chamber of Commerce & Industry (KADIN); Secretary of the Promotion Committee for Indonesia’s National Productivity Board (LPN); Member of Expert Working Group of National Food Security Council (DKP); to name a few.

Ms. Noraini Dato’ Mohd. Othman Senior Director- Food Safety & QualityMinistry of Health, Malaysia & ASEAN Expert Group onFood Safety (AEGFS)

Noraini Dato’ Mohd Othman joined the government service in 1982 and has been working extensively in the

area of food safety for the past 31 years. She continues to be vastly involved in food safety and has contributed significantly to Codex and food safety at the national, regional and international levels through various initiatives and forums. She has served as the Vice-Chairperson of the Codex Alimentarius Commission for 3 terms (2005-2008), expert reviewer of FAO/WHO documents, consultants on Codex & food safety to several countries and initiated various food safety works in the ASEAN region. She is currently a member of the Adviso-ry Group Member of the International Food Safety Authorities Network (INFOS-

Ms. Karen Roscom Executive Director, Bureau of Agriculture and Fisheries StandardsMinistry of Agriculture, Philippines

Karen Roscom is currently the Officer-In Charge (OIC)- Executive Director of the Bureau of Agriculture and Fisheries Standards (BAFS) of the Department of Agriculture in the

Philippines. The BAFS develops standards for agriculture and fishery products, tools, equipment and machinery. It is also the regulatory agency for organic agriculture mandated to implement the registration of organic inputs and products, and the accreditation of organic certifying bodies. Ms. Roscom is a graduate of food technology in the University of the Philippines and finished her Master of Food Service Administration, specializing on food safety, from the same university.

Ms. Malee Jirawongsy (appointed by Ms. Tipvon Parainyasiri) (Acting) Expert in Food StandardBureau of Food - Thailand

Malee Jirawongsy is currently Expert on Food Standard at the Bureau of Food, Food & Drug Admnistration (FDA), Ministry of Public Health, Thailand. She started her career

as a Food Technologist for the Manufacturing Plant Control Section, Food Control Division, at Thai FDA in 1981 after earning a BSc.degree (Home Economics, Food and Nutrition) from Kasetsart University. She worked at the Registration Section as Food Technologist, Senior Food Technologist for Beverage and Weight Control (Food Additives and Product Classification Sub-Section), and eventually moved to Dietary Supplement and Food for Special Dietary Use Sub-Section, Pre-Market Section. She was appointed as Expert on Food Standard since 2015.

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Dr. Vu Ngoc Quynh Director – CODEX OfficeVietnam Food Administration, Ministry of Health, Vietnam

Dr. Vu Ngoc Quynh is currently the Director of the Vietnam Codex Office under the Ministry of Health in Vietnam and is also the current Secretary General of the Vietnam National Codex Committee. Prior to his current roles, Dr.

Quynh served in various government positions related to animal quarantine, meat hygiene, veterinary public health and food safety where he was responsible for developing policies and legislations on animal quarantines, meat inspections and regulations of slaughter houses in Vietnam.

At an international level, Dr. Quynh has also been involved in SPS/WTO negotiation, an ADB project on facilitation of cross-border trade in GMG and a WB project on assessments of the regulatory gaps in Vietnam. Recently, Dr.Quynh has been representing his country in developing the Codex Standard for Fish Sauce and the Codex Code of Practice for Processing Fish Sauce

Dr. Tun Zaw Director/ Head - Food DivisionDepartment of Food and Drug Administrator, Myanmar

Since 2013, Dr. Tun Zaw is the Director of Food Safety at the Food and Drug Administration, Ministry of Health, Myanmar. From 2011-2013, he was the Deputy Director, and from 2007-2011, the Assistant Director. From

2000-2007 he was the Food Control Officer of the Food and Drug Administration (Upper Myanmar) Mandalay. Dr. Zaw has participated in over 32 international workshops on food safety. He holds a M.B., B.S., D.F.T., M.P.H.

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Ms. Sylvia Laksmi Sardy Senior OfficerASEAN Secretariat

Ms.Sylvia Laksmi Sardy has over 15 years of experience in the field of standardization and conformity assessment at national, regional and international levels and is also a certified auditor for ISO 9000, ISO 14000, Total Quality

Management (TQM) and Hazard analysis and critical control points (HACCP) standards. With experiences in project management at both regional & national levels, Ms. Sylvia is also a KAN assessor for HACCP, does product certification and implements greenhouse gases protocols (GHG).

Her areas of expertise lies in the certification and accreditation of systems, regional and national government & regulatory affairs, standards and conformity assessments, Reducing Emissions from Deforestation and Forest Degradation (REDD+), monitoring and evaluation of food standards, quality management systems for foodstuffs, HACCP assessment & food management systems and accreditation.

Mr. Teoh Keng Ngee Senior Manager – Scientific ProgramILSI Southeast Asia Region, Singapore

Keng Ngee Teoh is Senior Manager, Scientific Programs at the Southeast Asian branch of the International Life Sciences Institute (ILSI), which is a non-profit, worldwide organization whose mission is to provide science that

improves public health, particularly in the areas of food safety and nutrition. At ILSI Southeast Asia Region, Mr. Teoh is responsible for overseeing scientific projects that support the improvement of food safety technical infrastructure and capacities among ASEAN countries. Prior to this, he also worked at the World Health Organization in Geneva, Switzerland, as an intern in the Department of Food Safety and Zoonoses.

Ms. Sandra Callagan Head of Trade and Economic SectionDelegation of the European Union to Malaysia

Ms. Sandra Callagan is currently the Head of Trade and Economic Section of the Delegation of the European Union to Malaysia. She has over 7 years of experience as a negotiator, being the Lead Negotiator of Services and

then Trade Negotiator of Investments for the European Commission in 2013. Ms.Sandra also has a firm understanding of the inner workings of Asian countries as she has been based in Hanoi, Vietnam as the Head of Political and Economic Section, EC Delegation to Hanoi in 2007 and was the Deputy Head of Unit for Trade Relations with South East Asia in 2005 for the European Commission. Her expertise lies in foreign policies, negotiation, International Relations and conceptualizing & implementing strategies for the EU and local governments.

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Project Implemented by:SEBSEAM-MSupport for European Business in SouthEast Asia Markets Malaysia Component

Co-funded by:

Thanking all the speakers/panellists for your participation at the EU-ASEAN Forum 2015 in Kuala Lumpur, Malaysia on 8 December 2015. Your strong support, thought-provoking insights and stimulating discussions drove this forum to success. Your contribution ensured the success of the forum and even helped the forum achieve its goal which was to nurture the EU-ASEAN policy dialogue on food safety and food regulatory affairs. Till the next forum!

The EU-ASEAN Forum Committee 2015

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