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164 Agriculture, Food and Beverage (AFB) Working Group Section Three: Trade in Goods Key Recommendations 1. Standards Issues a. Food Additives in General • Issue necessary guidelines and training to clearly distinguish food additives from processing aids in implementing food safety regulations and standards. • Continue updating GB 2760 using a scientifically based approach with continuous reference to relevant international standards/codes such as FAO/WHO’s CODEX, JECFA to better incorporate new additives that are already extensively used worldwide. • Establish a fast track application process for food additives that offer no safety concerns, for example, those already listed in internationally recognised standards such as Codex and JECFA. • Develop and maintain an online version of GB 2760 that is updated in a timely manner, and made freely accessible for public consultation. b. Alcoholic Beverages Related • Update the standards defining Western alcoholic beverages to bring them in line with relevant international standards; particularly ensuring that the limits of the analytical parameters set for vodka will take into account those properties linked to flavoured vodkas. • Revise GB 2757-1981 to set methanol limits in accordance with relevant international standards so as to accommodate traditional European alcoholic beverage products such as Grappa and Tsipouro, fruit spirits, as well as Mexican tequila. c. Cheese Products Related • Remove the yeast limit for natural cheese in GB 5420-2010. • Revise cheese products standards and make more precise the application of microbiological criteria, bearing in mind the variety of cheese products and their characteristics. d. Paediatric Nutrition Related • Form a committee, in the absence of corresponding national standard, to review and approve special food registration on a case-by-case. • Develop a precise and in-depth national standard for Infant Formulas for Special Medical Purposes (IFSMP). • Establish relative regulations to guide the manufacturing, marketing, and use of IFSMP products. • Define and update the category under GB 2760 and GB 14880 for special products which should also account for the future development of standards. • Create a list in GB 14880-1994 of nutrient substances used in nutrition products for infants and children (infant formulae, follow-up formulae and growing-up formulae) and special nutrition products for infants and children (Formulae for Special Medical Purposes) without setting limits on usage. The usage levels of these nutrients should be in compliance with product standards. • Develop a national standard for General Standard of Food for Special Medical Purposes. • Develop a standards system based on international standards and supporting data from the FCC, USP, BP and others for the specification of individual food additives and nutrient fortifiers, in which specialized nutrition products should be included. e. Pet Food Related • Officially recognise the professional industry of Petcare in order to set up all relevant legislation and standards for the pet food industry. • Involve the Petcare Industry in the drafting procedure of regulations and standards so as to benefit from the industry’s know-how and international best practice. Agriculture, Food and Beverage (AFB) Working Group

Transcript of Agriculture, Food and Beverage (AFB) Working Group

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Key Recommendations

1. Standards Issues a. Food Additives in General • Issue necessary guidelines and training to clearly distinguish food additives from processing aids in

implementing food safety regulations and standards. • Continue updating GB 2760 using a scientifically based approach with continuous reference to relevant

international standards/codes such as FAO/WHO’s CODEX, JECFA to better incorporate new additives that are already extensively used worldwide.

• Establish a fast track application process for food additives that offer no safety concerns, for example, those already listed in internationally recognised standards such as Codex and JECFA.

• Develop and maintain an online version of GB 2760 that is updated in a timely manner, and made freely accessible for public consultation.

b. Alcoholic Beverages Related • Update the standards defining Western alcoholic beverages to bring them in line with relevant international

standards; particularly ensuring that the limits of the analytical parameters set for vodka will take into account those properties linked to flavoured vodkas.

• Revise GB 2757-1981 to set methanol limits in accordance with relevant international standards so as to accommodate traditional European alcoholic beverage products such as Grappa and Tsipouro, fruit spirits, as well as Mexican tequila.

c. Cheese Products Related • Remove the yeast limit for natural cheese in GB 5420-2010. • Revise cheese products standards and make more precise the application of microbiological criteria,

bearing in mind the variety of cheese products and their characteristics.

d. Paediatric Nutrition Related • Form a committee, in the absence of corresponding national standard, to review and approve special food

registration on a case-by-case. • Develop a precise and in-depth national standard for Infant Formulas for Special Medical Purposes (IFSMP). • Establish relative regulations to guide the manufacturing, marketing, and use of IFSMP products. • Define and update the category under GB 2760 and GB 14880 for special products which should also

account for the future development of standards. • Create a list in GB 14880-1994 of nutrient substances used in nutrition products for infants and children

(infant formulae, follow-up formulae and growing-up formulae) and special nutrition products for infants and children (Formulae for Special Medical Purposes) without setting limits on usage. The usage levels of these nutrients should be in compliance with product standards.

• Develop a national standard for General Standard of Food for Special Medical Purposes. • Develop a standards system based on international standards and supporting data from the FCC, USP,

BP and others for the specification of individual food additives and nutrient fortifiers, in which specialized nutrition products should be included.

e. Pet Food Related • Officially recognise the professional industry of Petcare in order to set up all relevant legislation and

standards for the pet food industry. • Involve the Petcare Industry in the drafting procedure of regulations and standards so as to benefit from the

industry’s know-how and international best practice.

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f. Feed Additives Related • Recognise the EU controls on the assessment and approval of feed additives and simplify the registration

process for the import of EU authorised feed additives into China given that General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) order 118 (2009) includes risk assessment.

• Ensure that the list of approved feed additives is in a publicly accessible government website which sets out conditions of the additives’ use and all aspects of registration.

2. Labelling Issues a. Labelling of Pre-packaged Food in General • Withdraw the requirement of QS labelling on food and beverage product packages and allow the existing

stocks of imported and domestic labels be used up. • Otherwise, extend the grace period of current QS requirement to at least three years starting from 1st June

2010. • Provide a sufficient transition period for the coordinated implementation of all revised labelling standards.

b. Nutrition and Health Claims • Make some exemptions to the mandatory nutrition labelling by taking into consideration of certain feasibility

issues and the international practices including the EU regulations. • Establish measures to allow administrative revision and approval of nutrition and health claims in a

scientifically-based manner. • Update and streamline methods of nutrient analysis to allow for the consistency of test results across the

country.

c. Application Procedure • Provide sufficient guidelines and training for all local offices of the Inspection and Quarantine Bureau of

the People’s Republic of China (CIQ) to ensure the consistency of interpretation and implementation of the regulations.

3. Certificate, Licence and Testing Issues a. Sanitary (Hygiene) Certificate for Imported Food & Beverage Products • Ensure sufficient hard and soft resources to speed up the processing of certificates. • Authorise independent and third-party certificated organizations and laboratories to satisfy the growing

demand of certificate and testing. • Continue to improve facilities on a national level and ensure adequate storage (particularly temperature

controlled storage) at both CIQ and Customs. • Ensure that Sanitary (Hygiene) Certificates issued at one port of entry will be accepted throughout China

without the need to apply for certificate filing for the same cargo in other cities where distribution occurs. • Provide a tracking system for certificate processing and timing.

b. E. Sakazakii Testing of Imported Dairy Products • Confirm E. Sakazakii testing requirement applies only to infant formulas.

4. Traceability Issues a. Food & Beverage Related • Protect existing foreign lot codes on imported products in the Chinese market so as to guarantee seamless

product traceability and facilitate product recall and impose penalties on those tampering with traceability information (lot codes) on food products.

• Acknowledge the need to fully and efficiently implement the Food Safety Law Recall provisions, ensure that food and beverage products entering the Chinese market bear an appropriate lot code and that this lot code or other tracing code made by the producers of food and beverage products should not be removed or damaged by on-sellers of such products.

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b. Feed and Feed Additives Related • Extend all the provisions of the Food Safety Law to cover ‘edible agricultural products and feed’ to help

ensure a high level of protection of public health, taking into account the protection of animal health and welfare.

• Provide the necessary mechanism to assess the risk of biological, chemical and physical hazards in manufactured feeds and feed ingredients.

• Introduce a supervisory system to ensure traceability of feed and feed additives from manufacturer to final user.

• Update existing Chinese feed legislation to bring it within this proposed framework.

5. Agriculture Issues a. Arable Farming • Adopt systematic and concrete measures to encourage land consolidation. • Encourage more efficient use of agro-chemicals, and provide training to all users of pesticides and fertilisers

to reduce over use and soil contamination issues. • Encourage the adoption of advanced seed technologies. • Protect agricultural Intellectual Property Rights. • Further invest in improvements in rural infrastructure.

b. Animal Nutrition I. Safety Control of Manufactured Feed and Feed Materials • Recognise the controls on the production, sale and supply of safe feed that have been brought into

operation in the EU, and for imported products adopt controls that are no more onerous to those imposed on products produced in China.

• Make specific reference to HACCP principles and train inspectors in likely hazards and effective controls. • Be transparent on the approval process for the registration of feeds. • Adopt a compulsory requirement for the suppliers, processors and producers of manufactured feed and

feed materials to be responsible for the information on the product label. • Ensure the catalogue for feed materials currently being prepared includes: a description of the product

concerned and, where appropriate, any process involved in its production, especially if there is the presence of any chemical impurities and/or processing aids.

• Recognise the EU catalogue as required under Regulation 767/2009 for imported feed materials. • Ensure the published list of undesirable substances applies to all manufactured feeds and feed materials. • Use the published list of registered and approved feed business operators to minimize the need for

resource intensive random visits (under AQSIQ decree 118 (2009), after having approved an EU member state regulatory framework).

• Ensure controls as defined in Regulation 118 are appropriately and consistently enforced to help protect the integrity of the Chinese export market.

II. Develop Assurance Programs for Quality and Safety in Animal Food Products • Work with feed companies to develop appropriate independent auditing schemes and professional

qualifications to ensure the quality and safety of animal feed. • Adopt an annual independent audit on all suppliers of feed ingredients as well as manufacturers to help

improve traceability. The audit should be done by an internationally accredited certification body specialising in feed and food assurance. There should be no cost or liability to the government for this process.

• Put into place a sufficient number of suitably qualified and experienced inspectors who possess adequate facilities and equipment to carry out their duties.

• Develop specialised training programmes for local inspectors to qualify as lead assessors, as well as provide updated information and knowledge. Training of inspectors should help to ensure that decisions on enforcement are undertaken throughout China in a uniform way; the methodology to be used for official tests should be available to the industry to enable manufacturers to carry out their own quality control of the products they use and produce.

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European Business in China Position Paper欧盟企业在中国建议书 2010 / 2011

Introduction to the Working GroupThe European Union (EU) plays a key role in the world trade of agricultural products, and food and beverages. It is now the world’s largest exporter1 (total EUR 58.2 billion, showing a 6.4% increase over 2007) and importer (total EUR 57.1 billion, showing an 8.4% increase over 2007) of food and drink products worldwide (excluding intra-EU trade with a total surplus of EUR 2 billion).

Following on from last year, China is still listed as one of the top ten export destinations for EU agricultural, food and beverage products worth approximately EUR 1.4 billion. This represents a year-on-year increase of 12.3% and a 216% increase from 2000 to 2008. Simultaneously, China’s exports of agricultural, food and drink products to the EU continue to grow with a total value in excess of EUR 3.3 billion in 2008. This is a 148% increase from 2000 to 2008.

The Food & Beverage Industry is the single largest manufacturing sector in the EU, with a total turnover of EUR 965 billion (accounting for 12.9% of manufacturing overall). This puts the Food & Beverage Industry ahead of the Automobile, and Chemical and Machinery industries. It is also the leading employer in the EU (13.5%), ahead of the Fabricated Metal and Machinery & Equipment industries. In terms of the number of companies, it is comprised of over 310,000 companies which range from large-scale multinational companies (MNCs) to small and medium-sized enterprises (SMEs). In the EU, an SME is defined as having less than 250 employees. SMEs contribute 48.7% of the aggregate turnover and account for 63% of total employment.

The performance of EU products in expanding markets such as China, measured as the share of food and drink imports originating from the EU compared to the share of imports originating from other countries, remains stable. On the other hand, food and drink imports to the EU from new agricultural markets, such as China, are becoming increasingly important. Established in 2003, the Agriculture, Food and Beverage (AFB) Working Group, aims to be a communication platform to facilitate dialogue and information exchange between European companies in the food and beverage sectors and their Chinese regulators or supervising

authorities. Ultimately, the group aims to foster positive discussions to ensure better understanding and implementation of policies and regulations, and greater levels of food safety.

The Working Group includes a wide range of companies in the food, beverage and agriculture sectors including importers, manufacturers and distributors of food and beverage products, food additives, animal feed, and feed additives; as well as catering service providers, specialised testing laboratories, food and beverage engineering companies and consultancies in marketing and food communication. In 2009, the working group was enlarged to incorporate both a Paediatric Nutrition sub-group, and companies in the agricultural sector, including agricultural products trading companies, agricultural products processors, agricultural machinery manufacturers and companies involved in animal feed. Currently the Working Group has 84 member companies with more than 250 participating individuals.

Recent DevelopmentsChina has made safety and quality within the Agriculture, Food, and Feed industries a national priority. The recently created Food Safety Law, National Food Safety Commission, and the Food Safety Work Plan 2010 are major steps in creating China’s nationwide system designed to protect both the industry and the consumers.

With these systems in place nationally, China aims to ensure quality at every step from farmer to fork. However, industry experts have noted that within the framework of these new laws and policies some issues remain that will hinder their overall implementation and feasibility. These issues are present both at the national and local levels. Some of the issues include: a lack of international standardization in processes or allowances thus inhibiting the ability of international and domestic producers to make full use of acceptable resources; the presence of unclear and overlapping administrative responsibilities that cause significant delays and increase costs; unclear implementation standards which result in a decreased ability to enforce food safety provisions; a lack of consistency in consolidation, training, and resources which creates risk to both food and feed safety. These areas of concern will each be improved by utilising insider knowledge from the domestic market and abroad, and through applying international standards that have been

1 All data from the Confederation of the Food and Drink Industries in the EU (CIAA)

2009 annual market report; ‘Data & trends of the European Food and Drink Industry

2009’.

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tested and proven through a scientifically based approach. China and the EU must continue to work together through open communication on improving the framework on which the Chinese Government has placed such a high priority.

Commitment to product safety on both sides reinforces a desire for trade. Improving coordination of trading standards and traceability will create a mutually beneficial atmosphere. Unfortunately, technical barriers to trade continue to impede imports of a number of European agricultural and food products into China. Even for experienced EU companies operating globally, the diversity of technical requirements and certification schemes coupled with a lack of predictability and consistency are a significant burden which may hamper trade development as companies incur significant delays and additional costs.

The European Chamber welcomes the continuous efforts to revise the existing food quality standards, health standards, and industry standards in order to: 1. address missing, duplicated, or conflicting problems in the standards; 2. establish a sound scientific and unified food safety standards system on the basis of risk assessment; 3. to extend the approach to cover feed and feed additives

The European Chamber members of the AFB Industry would like to continue working with China to ensure the highest standards of quality and safety within the Chinese AFB Industry. The AFB Working Group firmly believes in China’s commitment to these issues and welcomes the opportunity to have an open dialogue on behalf of the Industry with relevant authorities throughout China and the EU to make sure that the best interests of all are met.

Key Recommendations1. Standards Issues

The setting of standards is one of the key elements for the free flow of goods in international trade. China has taken into consideration the international principles in the standards making process and in general welcomes the participation of industry expertise in the drafting process. The European Chamber commends this pragmatic approach and hopes for continued openness during the evolution and development of the national standards system following the promulgation of the Food Safety Law covering both food and edible livestock products.

a. Food Additives in General ConcernThere are over 5,000 kinds of food additives approved for use in food products in the Codex list. But only roughly 2,000 of those are included in the Chinese Hygiene Standard for Uses of Food Additives (GB 2760-2007) as being approved for use in China.

Additionally, the current regulations and standards do not clearly distinguish between food additives and processing aids. When enforcing the regulations, local authorities often apply the same requirements for food additives on processing aids which adds unnecessarily to costs and reduces the efficiency of industry members.

AssessmentThe vast difference between Codex and GB 2760-2007, in terms of food additives, indicates that GB 2760 is lagging behind the international standard. The limited number of approved food additives in China has set obstacles for Food & Beverage Industry exporters targeting the Chinese market, which may also impede the free movement of food and beverages and create unequal competition.

The Working Group members agree that it is reasonable to be cautious in the registration procedure for novel and rare food additives. However, the Working Group maintains that a fast track should be in place to facilitate the registration procedure for food additives that offer no safety concerns, for example, those that have already been listed in Codex for many years, and which are used extensively worldwide. This will not only help lessen an enterprise’s operational burden but also optimise the administrative resources of government agencies.

In Europe, the distinction between a food additive and processing aid is defined in EU legislation (e.g. Directive 89/107/EEC). A food additive is considered to be any material added as a component of a food product for a technical purpose. Food additives are required to be food grade materials that are considered safe for consumption. The same food grade requirement is placed on materials which may come into contact with the final product during handling and storage, such as conveyer belts and greases. A processing aid is a material or chemical applied to the production process for a technological purpose, e.g. to improve efficiency or prevent undesirable conditions, but which will not have a direct effect on the final product. As processing aids will be removed from the process or excluded from the final product, having

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food grade processing aids is not considered an essential requirement. However, chemicals acting as processing aids used in the food industry must also comply with legislation which has deemed them safe to use in a food production process.

Therefore the European Chamber welcomes the newly revised GB 2760-2007, which calls for the restructuring of the currently used food additives standards into the same structure as Codex. However, the members of the Working Group have encountered difficulty in accessing up-to-date versions of GB 2760–2007. GB 2760–2007 is continually being updated and a consistently available, up-to-date, online version needs to be made available for public consultation.

Recommendation• Issue necessary guidelines and training to clearly

distinguish food additives from processing aids in implementing food safety regulations and standards.

• Continue updating GB 2760 using a scientifically-based approach with continuous reference to relevant international standards/codes such as FAO/WHO’s CODEX and JECFA to better incorporate new additives that are already extensively used worldwide.

• Establish a fast track application process for food additives that offer no safety concerns, for example, those already listed in internationally recognised standards such as Codex and JECFA.

• Develop and maintain an online version of GB 2760 that is updated in a timely manner, and made freely accessible for public consultation.

b. Alcoholic Beverages Related ConcernChinese General Classification Standard for Alcoholic Beverages (GB/T 17204-2008) and the specific product standards of Western alcoholic beverage products (GB/T 11856-2008 for brandy, GB/T 11857-2008 for whisky, and GB/T 11858-2008 for vodka) are not in conformity with relevant international standards for Western alcoholic beverages. The Working Group is concerned that these problems could potentially lead to consumer deception by allowing for the production and marketing of Western alcoholic beverage products which are subject to less stringent standards then those made in the EU with no guarantee of administrative or legal enforcement.

Also, the ongoing amendment proposal on Chinese Hygiene Standard for Distilled Spirits and Integrated Alcoholic Beverages (GB 2757-1981) sets a methanol

limit which could block traditional European grape marc spirits such as Grappa and Tsipouro, fruit spirits, as well as Mexican tequila from entering the Chinese market.

AssessmentI. The General Classification Standard of Alcoholic Beverage GB/T 17204-2008, adopted in 2008 only defines brandy, whisky, rum, gin and vodka, and these definitions are lacking in substance in the following aspects: a. Absence of minimum alcoholic strength for categories of

products without specific product standards such as gin or rum. This could potentially allow products of extremely low alcohol strength to be sold under the name of gin or rum, even though their taste would bear no likeness to the genuine product, and even lower versions could be allowed, thus blurring the difference between spirits, wine and beer.

b. There is presently no definit ion for other spirits categories, such as wine spirit, London gin, liqueurs, aquavit, bitters, etc.

The specific product standards (GB/T 11856-2008 for brandy, GB/T 11857-2008 for whisky, and GB/T 11858-2008 for vodka) are weaker than EU definitions in certain areas: a. The standards do not set specific distillation strength

for the ethyl alcohol used to make the various spirits categories. Maximum distillation strength is intended to prevent the addition of ethyl alcohol to products which have to retain the organoleptic characteristics derived from their raw materials. Conversely, minimum distillation strength is intended to ensure the quality of those other spirits relying on ethyl alcohol, so that the alcohol reaches the necessary level of purity. Therefore, the standard fails to make a fundamental distinction between spirits whose raw materials are not distilled all the way through for taste purposes (whisky, brandy, etc.) and spirits whose distillation is done at very high levels to better accommodate the use of flavourings (vodka, gin, aquavit etc).

b. Raw materials for vodka should be indicated when the materials used are not traditional (i.e. cereal or potato).

c. The use of flavourings is currently not prohibited in GB/T 11856-2008 for brandy and in GB/T 11857-2008 for whisky, however, it is defined in EU regulations.

d. Prohibition on the use or addition of ethyl alcohol. In the case of brandy (GB/T 11856-2008), however, it is allowed when using the term “blended brandy”. This expression may be confused by the consumer with “blended whisky,” which in Europe has a different

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meaning and is not allowed to contain ethyl alcohol at any time.

III. And they are overly stringent in other areas:a. Analytical parameters set in GB 11856 for brandy, GB/

T 11857 for whisky and GB/T 11858 for vodka are not in line with relevant international standards, such as the EU standards, and the limit on higher alcohol, which has been removed from the Chinese Hygiene Standard for Distilled Spirits and Integrated Alcoholic Beverages (GB 2751-1981), has been retained in GB/T 11858 for vodka. The limits of analytical parameters are particularly stringent for flavoured vodkas in the vodka related standard and not in line with international practices.

b. Limitations on naturally occurring substances for whisky (acetic acid, esters, etc.), vodka, and other ethyl alcohols.

IV. The currently proposed amendment on Chinese Hygiene Standard for Distilled Spirits and Integrated Alcoholic Beverages (GB 2757-1981), if adopted, would pose a threat to the trade given its mandatory nature, and that the proposed new limits on methanol levels are not in conformity with relevant international standards. For instance, the current limit on the level of methanol is based on a product classification that could potentially block Grappa and Tsipouro, traditional fruits based spirits, as well as Mexican tequilas from entering the Chinese market. Some products which are not subject to any methanol limitation in Europe would fall under the restriction of this new Chinese standard without any proper scientific justification for deviating from generally accepted standards in other regions of the world.

Recommendation• Update the standards defining Western alcoholic

beverages to br ing them in l ine wi th re levant international standards; particularly ensuring that the limits of the analytical parameters set for vodka will take into account those properties linked to flavoured vodkas.

• Revise GB 2757-1981 to set methanol l imits in accordance with relevant international standards so as to accommodate traditional European alcoholic beverage products such as Grappa and Tsipouro, fruit spirits, as well as Mexican tequila.

c. Cheese Products relatedConcernCheese naturally contains yeast. This yeast has been proven to be harmless to humans, and therefore should

not be subject to maximum restrictions in corresponding standards.

AssessmentYeasts are generally widespread in the environment because of their great capacity for adaptation to many substrates. It is completely normal to find yeast in dairy production and, moreover, lactic yeasts come about naturally. It has been proven that the presence of yeast in cheese products does not form any part of a recognised pathogenesis and thus does not present any danger to the consumer.

In other markets, such as the EU, where cheese consumption has a much longer history, there is no safety concern or limit set for yeasts in dairy products in general. More information can be found in European regulations concerning the hygiene of foodstuffs such as CE N°852/2004 and CE N°2073/2005.

In March 2010, China issued GB 25192-2010 and GB 5420-2010 both of which will come into effect on 1st December 2010 to replace GB 5420-2003. The Working Group appreciates the effort required to update the standards, but the members remain concerned that the maximal level of yeast is still restricted to 50 cfu/g. This restriction is not possible for natural cheese and does not take into account the manufacturing techniques of natural cheese which are different from processed cheese. The Working Group is concerned about the application of the microbiological criteria for yeast and mould as indicators for the safety and quality of cheese. The microbiological criteria for yeast and mould should only be applicable when a proper interior sample is taken. Without a proper sample, the general criteria will lead to confusion, given the varied characteristics of different types of cheeses.

Recommendation• Remove the yeast limit for natural cheese in GB 5420-

2010.• Revise cheese products standards and make more

precise the application of microbiological criteria, bearing in mind the variety of cheese products and their characteristics.

d. Paediatric Nutrition Related ConcernThe missing and incomplete standards of paediatric

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nutr i t ion hamper the Chinese customers’ access to products that are indispensable for the dietary management of special needs individuals.

AssessmentSpecial products designed specifically to meet the particular nutritional requirements of infants and young children with a specific disease, disorder or medical condition are indispensable for the dietary management of these individuals and are to be used in accordance with medical advice. At the time of writing, the new National Standard of Infant Formula for Special Medical Purposes (IFSMP) is still being drafted. However, without clarification of the definition of an IFSMP, controversy will occur during implementation.

Equally problematic is that certain food additives commonly used in international Baby Food Industry are not listed in GB 2760-2007. Also, according to GB 14880-1994, the levels of nutrient substances to be included in the product are based on the definition of fortified foods, which differs from the principle of product design for baby foods and therefore cannot meet the production requirements. The use of food additives should also take into account the know-how and technical needs of the manufacturer.

In the case of new product development and sales it is indispensable for manufacturers to carry out clinical trials before launching these new products in the market. Such compulsory steps should also be stipulated in the IFSMP standard so as to better protect the consumer’s interests and rights.

In line with this, there is a need for Food for Special Medical Purposes. This food is typically for those recovering from surgery. Similar products do currently exist in the overseas markets but cannot be introduced to Chinese customers due to the lack of related standards.

Another concern is in regard to the lack of a nationally applied standards system for the registration of individual food additives or nutrient fortifiers. Without this system it is possible for redundant registrations with minor deviations to occur. The Working Group thus suggests that MOH start to develop such a standards system.

Recommendation• Form a committee, in the absence of corresponding

national standard, to review and approve special food registration on a case-by-case.

• Develop a precise and in-depth national standard for Infant Formulas for Special Medical Purposes (IFSMP).

• Establish relative regulations to guide the manufacturing, marketing, and use of IFSMP products.

• Define and update the category under GB 2760 and GB 14880 for special products which should also account for the future development of standards.

• Create a list in GB 14880-1994 of nutrient substances used in nutrition products for infants and children (infant formulae, follow-up formulae and growing-up formulae) and special nutrition products for infants and children (Formulae for Special Medical Purposes) without setting limits on usage. The usage levels of these nutrients should be in compliance with product standards.

• Develop a national standard for General Standard of Food for Special Medical Purposes;

• Develop a standards system based on international standards and supporting data from the FCC, USP, BP and others for the specification of individual food additives and nutrient fortifiers, in which specialized nutrition products should be included.

e. Pet Food RelatedConcernThere are a significant number of pet food manufacturers and their products in the Chinese market, particularly at the lower end of the industry. However, there is currently a grey area between the Feed and Pet Food Industry and no specific standard has yet been applied to the Pet Food Industry.

AssessmentWithout an official definition of the pet food industry, application of standards of the raw material specification, GHP/GMP and food safety of pet food can vary widely and remain subject to individual interpretations. With no recognition of pet food as a professional industry and with no specific legislation pertaining to it, an unregulated market has developed where people can manipulate the ambiguity of standards so as to avoid product quality obligations that eventually put animal health and safety as risk.

Recommendation• Officially recognise the professional industry of Petcare

in order to set up all relevant legislations and standards for the pet food industry.

• Involve the Petcare Industry in the drafting procedure of regulations and standards so as to benefit from the industry’s know-how and international best practice.

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f. Feed Additives RelatedConcernWhere feed additives have already been approved in the EU, valuable resources in China could be better appropriated through having a fast track registration system.

AssessmentProvided controls underpinning additive approval in the EU meet controls in place in China, feed additives that have already been approved should be more readily available to the Feed Industry via a fast track system. There is already a comprehensive regulation in the EU on the assessment and approval of feed additives. New provisions are being introduced in China that are designed to improve the supervision and management of new feed additives. The Working Group would welcome the opportunity to work with the Chinese authorities in developing and implementing this legislation.

Recommendation• Recognise the EU controls on the assessment and

approval of feed additives and simplify the registration process for the import of EU authorised feed additives into China given that General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) order 118 (2009) includes risk assessment.

• Ensure that the list of approved feed additives is in a publicly accessible government website which sets out conditions of the additives’ use and all aspects of registration.

2. Labelling Issues

Labelling of food and feed products is governed by several regulations and standards in China. At the time of writing, the revised National Standard for the Labelling of Pre-packaged Food (GB 7718-2004), the Feed Labelling Standard(GB10648-1999) and the newly proposed National Standard for the Nutrition Labelling of Pre-packaged Food are being drafted. The Working Group members have appreciated the chance to make comments on the drafts and hope the industry’s opinion will be taken into account while finalising the standards.

a. Labelling of Pre-packaged Food in GeneralConcernIn practice, the Working Group members are facing several issues when revising labels in light of the new Food Safety Law.

AssessmentIn April 2010, AQSIQ issued an order on the Revision of Industrial Products Manufacturing License Label (Order 130). Order 130 together with Circular 34 on the Implementation Rules for Enterprise Food Manufacturing License Label and Circular 39 on Enterprise Product Manufacturing License Label requested the modification of the Quality & Safety (QS) label. However, point 8 of Article 42 in the Food Safety Law has specified the labelling requirement of the manufacturer licence number but not the QS label. The manufacturing license number indicates the production approval status. The QS label will provide redundant information.

There are a myriad of food and beverage products that all require different types of production methods, all of which can be expensive and can have varying impacts on the environment. There are more than 100 thousand licensed food manufacturers in China; of which, each of them has anywhere from a few dozen to over a thousand labels. Therefore the cost to the manufacturer to change the label is prohibitive especially when it is not relevant to product safety.

At the time of writing, the revised national Food Safety Standard for the labelling of pre-packaged foods and the new standard for nutrition labelling are not yet finished. The Working Group encourages the revision authorities to work with the industry before concluding the revision in order to ensure that only the most effective standards for both the authorities and the industry are put into effect.

Recommendation• Withdraw the requirement of QS labelling on food and

beverage product packages and allow the existing stocks of imported and domestic labels be used up.

• Otherwise, extend the grace period of current QS requirement to at least three years starting from 1st June 2010.

• Provide a sufficient transition period for the coordinated implementation of all revised labelling standards.

b. Nutrition and Health Claims ConcernThe Provision on Food Nutrition Labelling has been changed to the National Standard for Nutrition Labelling of Pre-packaged Foods. At the time of writing, the MOH is calling for comments on the draft standard.

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AssessmentNutrition labelling is significantly different from the conventional labelling of food ingredients. In food nutrition labelling the amount of a nutritional component must be analyzed. It is possible that different methods of analysis may have differing results Therefore, without specifying the method of analysis, one may find discrepancies between test results obtained from different methods. Additionally, the complexity of nutritional labelling requires that relevant government officials be professionally trained in testing methodology and nutrient knowledge. Last but not least, Chinese customers need considerable education in order to be able to recognise and interpret the nutrition and health claims on the labels which help to facilitate their choices. Given the absence of the aforementioned factors, it is not feasible to have consistent and effective implementation of the newly proposed food safety standard.

The EU rules on nutrition labelling are currently provided through the Council Directive 90/496/EEC, under which the nutrition labelling is voluntary. The new EC proposals on nutrition labelling are to make it mandatory on the front of pack for the majority of processed foods with certain exemptions. The final regulation is expected to be adopted during the next 18 months and the changes to the existing rules would become fully into effect 3 to 5 years after the promulgation.

Recommendation• Make some exemptions to the mandatory nutrition

labelling by taking into consideration of certain feasibility issues and the international practices including the EU regulations.

• Establish measures to allow administrative revision and approval of nutrition and health claims in a scientifically-based manner.

• Update and streamline methods of nutrient analysis to allow for the consistency of test results across the country.

c. Application ProcedureConcernWith regards to the application procedure, labelling regulations are not being thoroughly and uniformly interpreted, and implemented throughout the country.

AssessmentThe European Chamber welcomes, in principle, the 2006 AQSIQ Notice No. 44, ‘Notice on Modifying the Labelling

Audit System for Import and Export Foods and Cosmetics,’ which took effect on 1st April 2006. This renders the pre-labelling verification process by central AQSIQ unnecessary and shows AQSIQ’s attempts to improve the labelling process.

While the abolishment of the pre-labelling verification procedures should lead to a more efficient process for companies importing food and beverage products into China, industry members continue to encounter widespread inconsistencies in regulation interpretation and fulfilment three years after the initial implementation. The lack of pragmatic guidelines and training at the local China Inspection and Quarantine Service (CIQ) offices has hampered the implementation and has thus prevented the delivery of positive results.

Also, the lack of a coordinated national system has meant that some companies have encountered a situation whereby a label accepted at one port of entry is refused at another. This causes unnecessary delays and costs to the importer. It should be the case that if a label has been given approval by one office of the CIQ it is recognised nationally and will then be automatically approved by all other CIQ offices.

Recommendation• Provide sufficient guidelines and training for all local CIQ

offices to ensure the consistency of interpretation and implementation of the regulations.

3. Certificate, Licence and Testing Issues

a. Sanitary (Hygiene) Certificate for Imported Food & Beverage ProductsConcernThree key issues continue to jeopardize businesses: 1. Continued unpredictability and inconsistency in both testing time and methodology; 2. Sanitary (Hygiene) Certificates issued in one location are not accepted in others; 3. There is a lack of adequate storage facilities at ports of entry.

AssessmentIt is essential to obtain a Sanitary (Hygiene) Certificate before Customs clearance. However, this testing process can be lengthy with little clarity on timing required for approval. The availability of a timing reference for certificate processing can help the importer/distributor to better prepare and plan.

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In order to speed up testing and achieve efficiency, it is essential for authorities to be equipped with sufficient resources. The Working Group is concerned about laboratory issues, which include a lack of transparency of testing methodology, lab facilities, and professional training of staff. There are currently only state-owned labs involved in testing and these are seriously overloaded. It is suggested that the government authorise independent and third-party laboratories to satisfy the growing demands for these labs.

As far as testing standards are concerned, sufficient guidelines and technical training are needed to ensure consistency and transparency of interpretation at all local CIQ offices throughout China. The Working Group also suggests that hygiene certificates issued in one location be accepted by CIQ in other locations.

In instances where distribution takes place in an area other than the port of entry, importers/distributors are asked to apply for certificate filing for the same cargo and pay ‘local application fees’ again in the distribution area. This duplicate registration and fee brings forth unnecessary delays and burdens for importers/distributors, which could also eventually hamper the government’s efforts to control food price inflation.

Finally, while significant improvements have been made over the past ten years in providing storage facilities for imported goods at local CIQ and Customs Houses, the national average is much lower than what the industry requires. Greater investment is still needed to ensure that storage facilities meet the actual requirements of both importers and distributors.

Recommendation• Ensure sufficient hard and soft resources to speed up

the processing of certificates.• Authorise independent and third-party certificated

organizations and laboratories to satisfy the growing demand of certificate and testing.

• Continue to improve facilities on a national level and ensure adequate storage (particularly temperature controlled storage) at both CIQ and Customs.

• Ensure that Sanitary (Hygiene) Certificates issued at one port of entry will be accepted throughout China without the need to apply for certificate filing for the same cargo in other cities where distribution occurs.

• Provide a tracking system for certificate processing and timing.

b. E. Sakazakii Testing of Imported Dairy ProductsConcernSince 1st October 2005 all imported shipments of dairy products have to be sampled and tested by the CIQ for the E. Sakazakii bacteria. The testing procedure takes several weeks and requires that inspection documents be release before the goods can enter the market. Due to the length of time for testing and processing European companies often face serious problems in supplying their Chinese customers, and incur unnecessary financial losses.

Assessment E. Sakazakii is a micro-organism that occasionally causes a very rare form of food-borne illness in premature or otherwise ‘at-risk’ infants. In the past 40 years, only about 60 cases of this illness have been reported worldwide. In most of these cases the illness was linked to either the consumption of powdered soy or dairy based infant formula or to their contamination during preparation. There have been only eight cases of E. Sakazakii infection reported in adults in that same time frame. In each of these cases, no connection to food could be made and the adults infected were suffering from underlying health problems.

There is no evidence that E. Sakazakii poses any significant risk when food products comply with recognised international food processing or public health standards. As E. Sakazakii has no special significance in general purpose foods, no regulatory authority is known to have carried out a risk analysis for E. Sakazakii in these foods. Reports published by international food organisations such as the Food and Agricultural Organisation (FAO), World Health Organization (WHO), the Codex Committee on Food Hygiene (CCFH), and the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) all suggested limiting the testing for E. Sakazakii to infant formula only.

Hence there is no public health justification for testing for the presence or for setting microbiological limits of E. Sakazakii in any products destined for general consumption.

Recommendation • Confirm that the E. Sakazakii testing requirement applies

only to infant formulas

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4. Traceability Issuesa. Food & Beverage Related Concern The newly adopted Chinese Food Safety Law highlights the importance of the food recall system. While welcoming the initiative of the Chinese Government to better protect the consumer’s rights and interests, the Working Group is concerned that the absence of measures to facilitate traceability impedes an enterprise’s capability to trace and recall imported products. Should this happen, it poses a threat to local consumers and hampers an enterprise’s capability to cooperate with the Chinese government on food safety initiatives.

Assessment Under EC regulation, all food and beverage products manufactured in the EU must be labelled with a lot code. Thus, all products exported from the EC will bear a manufacturer’s lot code at the time of export. EC regulations also require manufacturers of food and beverage products in the EU to provide a mechanism that allows traceability of its products throughout the supply chain. These lot codes then allow for an effective product recall system if a recall is required.

However, there have been cases where the genuine products imported had their trace codes intentionally removed before the products entered the Chinese market. Removal of the original manufacturer’s lot code greatly hampers a manufacturer’s ability to trace and recall a product globally in the event of a problem. Importation of food and beverage products without the original manufacturer’s lot code allows the importation of tampered products, reduces the global traceability of products, and unnecessarily increases the risk to local consumers. Hence penalties should be imposed on those tampering with lot codes on food products.

Recommendations• Protect existing foreign lot codes on imported products

in the Chinese market so as to guarantee seamless product traceability and facilitate product recall and impose penalties on those tampering with traceability information (lot codes) on food products.

• Acknowledge the need to fully and efficiently implement the Food Safety Law Recall provisions, ensure that food and beverage products entering the Chinese market bear an appropriate lot code and that this lot code or other tracing code made by the producers of food and

beverage products should not be removed or damaged by on-sellers of such products.

b. Feed and feed additives relatedConcernMany food scares have their origin in manufactured feed and feed ingredients (feed materials and feed additives) used to feed livestock. This causes great concern among the general population in China and consequent lack of confidence in feed and food producers as well as the authorities. It has also alerted countries which import Chinese feed ingredients to the need to assess the risks of such goods before use.

AssessmentThe availability of wholesome feed and feed additives, free from contaminants, is essential for the feed and food industry in China. Only certain chapters of China’s Food Safety Law, effective on 1st June 2009, apply to ‘edible agricultural products’ and, thereby, livestock products. A supervisory system to ensure traceability of products from manufacturer to final user would assist in any recall procedure when and where necessary.

Recommendations• Extend all the provisions of the Food Safety Law to

cover ‘edible agricultural products and feed’ to help ensure a high level of protection of public health, taking into account the protection of animal health and welfare.

• Provide the necessary mechanism to assess risks of biological, chemical and physical hazards in manufactured feeds and feed ingredients.

• Introduce a supervisory system to ensure traceability of feed and feed additives from manufacturer to final user.

• Update the existing Chinese legislation on feed to be brought within this proposed framework.

5. Agriculture Issuesa. Arable FarmingConcern Although the Chinese Government is encouraging land consolidation for rural areas, local farmers lack the incentives and regulations needed for them to change their land status. For foreign investors in the agriculture sector or food processing industries, land consolidation is usually an important condition for promoting mechanisation, introducing advanced technologies to agriculture, and improving crop yield and quality. The implementation of favourable regulations would assist both the growers and

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investors in achieving an increase in overall yield.

Also affecting growers is the use of pesticide, herbicide, and other agro-chemicals. These chemicals are produced and sold by numerous factories and dealers. Although both central and provincial governments have attached great importance to supervising this market, the regulations and enforcement are far from sufficient to ensure product safety and quality.

In the Guidance of Foreign Investment Industries promulgated in November 2007 by the National Development and Reform Commission (NDRC), foreign investment in relevant seed technologies is listed in either restricted or prohibited catalogues. This is also true for some cereal processing industries. It is understood that China needs to keep control over the seed sector because of national security concerns. However, the explicit restrictions and inflexible enforcement of the policies prevent China from gaining access to many of the most advanced seed technologies in the world. Intellectual Property Rights (IPR) is also an issue of great concern on the part of the European companies when investing in Chinese agriculture sectors.

Assessment Land sufficiency, crop yield and agricultural productivity remain the key elements to ensure long term sustainable national food security. There are several key elements that are required to achieve the maximum benefit including land consolidation, knowledge sharing, investment, and effective use of agro-chemicals. However, the critical changes which are required in order to make these improvements cannot happen without land consolidation.

Then once consolidation has been achieved technologies and best practice from Europe can help to accelerate China’s plan to upgrade arable practices to increase yields. Access to these technologies and know-how requires a more open approach to foreign investment. The total foreign direct investment (FDI) in the sector accounts for only 2% of the total foreign investment amount that China receives from the world. Regulatory restrictions on many agricultural processing industries discourage foreign investors from committing substantial investment in this area for any length of time.

More efficient use of proven modern agro-chemicals would help also improve yields, improve food quality and safety, and eliminate highly toxic chemicals. Recently

the presence of toxic vegetable products in some areas has raised concern. This increases the relevance of facilitating market entry for internationally established chemical products which will offer safer and more efficient alternatives.

Meanwhile, the Working Group suggests the government further improve transparency and decision-marking within rural investment projects to ensure efficiency. Private sector investment in irrigation systems, road building, and electricity supplies can also be encouraged to attract more capital.

Recommendations• Adopt systematic and concrete measures to encourage

land consolidation.• Encourage more efficient use of agro-chemicals and

provide training to all users of pesticides and fertilisers to reduce over use and soil contamination issues.

• Encourage/adopt advanced seed technologies.• Protect agricultural IPRs.• Further invest in improvements in rural infrastructure.

b. Animal NutritionImproved efficiency and efficacy within the animal feed sector in Europe was a result of adopting simple, practical controls that were developed jointly by the Industry and the Regulators at no cost to the Government. Developing standard assurance schemes for different aspects of the feed supply chain would help to deliver legislative requirements within the market. Practical controls and comprehensive assurance schemes would be an excellent way to support and sustain growth of the animal feed sector in China.

I. Safety Control of Manufactured Feed and Feed MaterialsConcernThere should be measures in place to ensure the safety of manufactured feeds and feed materials with equivalent controls on both imported and exported products.

AssessmentThe feed industry in China should be able to use wholesome feed materials. There are comprehensive legislative controls in place in the EU which include, under feed hygiene measures, provisions on the need to adopt hazard analysis and critical control points (HACCP) principles, provisions on undesirable substances, and a recently agreed upon regulation on the marketing and use of feed. Equivalent controls in China would be valuable.

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Equally, the ability to import feed materials from the EU produced under these controls with minimal additional regulation would be beneficial.

Recommendations• Recognise the controls on the production, sale and

supply of safe feed that have been brought into operation in the EU, and for imported products adopt controls that are no more onerous to those imposed on products produced in China.

• Make specific reference to HACCP principles and train inspectors in likely hazards and effective controls.

• Be transparent on the approval process for the registration of feeds.

• Adopt a compulsory requirement for the suppliers, processors and producers of manufactured feed and feed materials to be responsible for the information on the product label.

• Ensure the catalogue for feed materials currently being prepared includes: a description of the product concerned and, where appropriate, any process involved in its production, especially if there is the presence of any chemical impurities and/or processing aids.

• Recognise the EU catalogue as required under Regulation 767/2009 for imported feed materials.

• Ensure the published list of undesirable substances applies to all manufactured feeds and feed materials.

• Use the published list of registered and approved feed business operators to minimize the need for resource intensive random visits (under AQSIQ decree 118 (2009), after having approved an EU member state regulatory framework).

• Ensure controls as defined in Regulation 118 are appropriately and consistently enforced to help protect the integrity of the Chinese export market.

II. Develop Assurance Programs for Quality and Safety in Animal Food ProductsConcernThe legislation controlling the production of safe animal feeds is onerous and complex. Producers of feed ingredients, including additives, and finished feeds can range in size from very large companies to very small organizations. In order to ensure that the integrity of the feed and food chain is maintained and the legislation is fully complied with, all producers would greatly benefit from guides for good practice.

AssessmentMost feed scares have their origins in the feed ingredients

used. Ensuring feed ingredients at the source is the most cost-effective way of controlling most feed-related hazards before they happen.

In European countries, three schemes have been developed to cover feed ingredients, feed manufacture and sales, combinable crops, and their transport and storage. They are inter-related and include legal compliance, risk assessment (HACCP), good manufacturing practice (GMP), system controls (similar to ISO 9001), and traceability. There is also a fertiliser industry assurance scheme (FIAS) in the UK which covers fertiliser security and traceability.

Since 2006, under the feed hygiene regulation, the EC has encouraged the development of Community Guides to good practice in the feed sector and for the application of HACCP principles. Both the European Feed Manufacturers’ Code (EFMC), covering the manufacture of compound feeding stuffs, and FAMIQS which is a quality system for feed additives and pre-mixtures have been positively assessed.

Guides should be used as an important part of the enforcement risk assessment. Companies using Guides can therefore have an assured status which will help to improve the efficiency of the inspection process.

Recommendations• Work with feed companies to develop appropriate

independent auditing schemes and professional qualifications to assure quality and safety of animal feed.

• Adopt an annual independent audit on all suppliers of feed ingredients as well as manufacturers to help improve traceability. The audit should be done by an internationally accredited certification body specialising in feed and food assurance. There should be no cost or liability to the government for this process.

• Put into place a sufficient number of suitably qualified and experienced inspectors who possess adequate facilities and equipment to carry out their duties.

• Develop specialised training programmes for local inspectors to qualify as lead assessors, as well as provide updated information and knowledge. Training of inspectors should help to ensure that decisions on enforcement are undertaken throughout China in a uniform way; the methodology to be used for official tests should be available to the industry to enable manufacturers to carry out their own quality control on the products they use and produce.

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AbbreviationsAQSIQ General Administration of Quality Supervision, Inspection and QuarantineCCFH Codex Committee on Food HygieneCCNFSDU Codex Committee on Nutrition and Foods for Special Dietary UsesCIAA Confederation of the Food and Drink industries in the EUCIQ Inspection and Quarantine Bureau of the People’s Republic of ChinaEFMC European Feed Manufacturers’ Code EC European CommissionEU European UnionFAO Food and Agricultural Organization (of the United Nations)FCM Food Contact MaterialFDI Foreign Direct InvestmentFEMAS Feed Materials Assurance Scheme FIAS Fertiliser industry assurance schemeFSANZ Food Standard Australia New ZealandGB Guo Biao (National Standard)GMO Genetically Modified Organisms

GMP Good Manufacturing PracticeHAACP Hazard Analysis and Critical Control PointsHCP Health care professionalIT Information TechnologyIFSMP Infant formula for special medical purposesMNC Multinational CompanyMOFCOM Ministry of Commerce of the People’s Republic of ChinaMOH Ministry of HealthNDRC National Development and Reform CommissionPRC People’s Republic of ChinaQS Quality & SafetyRASFF Rapid Alert System for Food and FeedR&D Research and DevelopmentSME Small and Medium-sized EnterprisesSPS Sanitary and PhytosanitaryTASCC Trade Assurance Scheme for Combinable Crops UFAS Universal Feed Assurance SchemeWHO World Health Organization