EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Directorate F - Food and Veterinary Office

DG(SANCO) 2009-8158 - MR FINAL

FINAL REPORT OF A MISSION

CARRIED OUT IN

HONG KONG SPECIAL ADMINISTRATIVE REGION, CHINA

FROM 30 NOVEMBER TO 03 DECEMBER 2009

IN ORDER TO ASSESS THE OFFICIAL CONTROLS SYSTEMS IN PLACE FOR FOOD CONTACT MATERIALS FOR EXPORT TO THE EU TO PREVENT MIGRATION OF THEIR CONSTITUENTS INTO FOOD.

In response to information provided by the Competent Authority, any factual error noted in the draft report has been corrected; any clarification appears in the form of a footnote. Executive Summary This report describes the outcome of a mission carried out by the Food and Veterinary Office (FVO) in the Kong Special Administrative Region of the People's Republic of China (hereinafter referred to as "") from 30 November to 3 December 2009.

The objective of this mission was to assess the official control systems in place for Food Contact Materials (FCM) to be exported to the European Union.

There is no Competent Authority (CA) designated for the export control of FCM or controls of FCM trans-shipped from mainland China via Hong Kong. Moreover, there is no legal basis for FCM control exported from Hong Kong (including products produced in mainland China). There are two CAs responsible for the control of FCM marketed in Hong Kong. Activities regarding FCM controls in the domestic market are organised in the form of surveys and focus on the issues identified through the CA risk assessment and consumer complaints. There is no registration system of FCM manufacturers in Hong Kong, however the mission team was informed by Hong Kong traders representatives that there is no FCM manufactured in Hong Kong exported into the EU. According to the CA the vast majority of FCM manufactured in mainland China and exported into EU by Hong Kong traders are directly shipped from mainland China without actually passing Hong Kong territory. When consignments are trans-shipped from mainland China via Hong Kong the customs authorities are not notified of products passing through Hong Kong and therefore no export control of FCM takes place. There are procedures in place for the communication and investigation of RASFF notifications in Hong Kong, however there is a very limited communication between Hong Kong CAs and the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China ( AQSIQ), the CA responsible for FCM controls in mainland China, with regard to the outcome of the RASFF investigations by Hong Kong authorities. There are number of well equipped and staffed FCM laboratories at the disposal of FCM manufacturers and traders to conduct migration testing to EC standards. However, the analytical methodology of visited laboratories was limited and did not cover the main substances notified through the RASFF (e.g. primary aromatic amines). Overall, the Hong Kong authorities have no legal basis for FCM control transited from mainland China via Hong Kong into EU even though these products are not controlled to EU standards in China. Given the current status it is not possible for Hong Kong authorities to implement export controls. The report makes a number of recommendations to the competent authorities of Hong Kong to address the deficiencies noted.

I Table of Contents

1 INTRODUCTION ...... 1 2 OBJECTIVES OF THE MISSION ...... 1 3 LEGAL BASIS FOR THE MISSION ...... 2 4 BACKGROUND ...... 2 4.1 B ACKGROUND TO PRESENT MISSION ...... 2 4.2 PUBLIC HEALTH INFORMATION ...... 2 5 FINDINGS AND CONCLUSIONS ...... 3 5.1 LEGAL REQUIREMENTS ...... 3 5.2 COMPETENT AUTHORITIES ...... 3 5.3 LEGISLATION ...... 4 5.4 COMPETENT AUTHORITY CONTROLS ...... 5 5.5 TRADE INFORMATION ON FOOD CONTACT MATERIALS PRODUCTION ...... 7 5.6 EXPORT PROCEDURES ...... 7 5.7 RESPONSE TO RASFF NOTIFICATIONS ...... 8 5.8 OFFICIAL CONTROL LABORATORY SERVICES ...... 8 6 OVERALL CONCLUSIONS ...... 11 7 CLOSING MEETING ...... 11 8 RECOMMENDATIONS ...... 11 ANNEX 1 - LEGAL REFERENCES ...... 12

II ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation Explanation AQSIQ General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China

BPB Boundary and Ports Branch CA Competent Authority CEDB Commerce and Economic CFS CPB Consumer Protection Bureau C&ED Customs and Excise Department DEHA Bis(2-ethylhexyl) adipate EC European Communities EN European Norm EU European Union FEHD Food and Environmental Hygiene Department FCM Food contact materials FRL Food Research Laboratory FVO Food and Veterinary Office GMP Good Manufacturing Practice HKAS Hong Kong Accreditation Service HKD ISO International Standard Organisation MS Member State PAA Primary aromatic amines PT Proficiency test PVC Polyvinyl chloride SML Specific migration limit US FDA United States Food and Drug Administration

III 1 INTRODUCTION

This mission took place in the Hong Kong Special Administrative Region of the People's Republic of China ( hereinafter referred to as "Hong Kong") from 30 November to 3 December 2009. The mission team comprised two inspectors from the Food and Veterinary Office (FVO) and one Member State (MS) expert.

The mission was undertaken as part of the FVO’s planned mission programme.

The inspection team was accompanied during the whole mission by representatives from the competent authorities (CA) the Food and Environmental Hygiene Department (FEHD) and the Customs and Excise Department (C&ED).

An opening meeting was held on 30 November 2009 at the Commerce and Economic Development Bureau (CEDB) with the CAs and the Trade and Industry Department of CEDB. At this meeting, the objectives of and the itinerary for the mission were confirmed by the inspection team, and additional information necessary to complete the mission satisfactorily was requested.

2 OBJECTIVES OF THE MISSION

The objective of the mission was:

• To assess the official control systems in place on food contact materials (materials and articles intended to come into contact directly or indirectly with food) for export into the European Union to prevent migration of their constituents into food, in particular primary aromatic amines and plasticisers from plastics, lead and cadmium from ceramic wares and formaldehyde from melamine kitchenware. With regard to food contact materials an assessment should be made that these materials and articles can be manufactured within specified European Union migration limits and in line with Regulation (EC) No 1935/2004. To achieve these objectives, the following sites were visited in accordance with the itinerary agreed between the CA and the FVO of the European Commission:

Competent Authority visits Comments Central 2 FEHD C&ED Laboratory visits 3 Government Laboratory Food Research Laboratory Private Laboratory Visit to premises 2 Traders of plastics and metal FCM Others 1 Meeting with Industry Associations: Hong Kong Exporters Association

1 3 LEGAL BASIS FOR THE MISSION

The mission was carried out in agreement with the two CAs and under the general provisions of Community legislation, specifically: • Regulation (EC) No 882/2004 of the European Parliament and of the Council, in particular Article 46.

All legal references relevant to this mission are listed in Annex 1. Legal acts quoted refer, where applicable, to the last amended version.

Other legislation relevant to this report is listed in the Annex.

4 BACKGROUND

4.1 B ACKGROUND TO PRESENT MISSION

Hong Kong is a special administrative region of the People's Republic of China. Under the Basic Law, Hong Kong Special Administrative Region enjoys a high degree of autonomy in accordance with the principle of "one country, two systems". According to this principle, Hong Kong remains a free port, a separate customs territory and an international financial centre and may, on its own, using the name of “Hong Kong, China”, maintain and develop relations, and conclude and implement agreements with foreign states and regions, and international organisations in appropriate field, including the economic, trade, fiscal, financial and monetary, shipping, communication, tourism, cultural and sports matters. The Central Government of the People's Republic of China is responsible for the foreign affairs relating to the Hong Kong.

Article 50 of Regulation (EC) No 178/2002 requires that information on foodstuffs and feedingstuffs found to have public health implications is disseminated as notifications through the Rapid Alert System for Food and Feed (RASFF) to all MS and to the exporting country. From 2004 to the time of the mission, the Commission services have recorded 142 notifications relating to FCM from Hong Kong or imported via Hong Kong, 78 of them related to the presence of primary aromatic amines (PAAs) from black nylon kitchen utensils, heavy metals from ceramic wares, high levels of formaldehyde from melamine kitchen wares, plasticizers from plastics and overall migration. The breakdown by year of these notifications is as follows: 4 notifications in 2004, 23 notifications in 2005, 27 notifications in 2006, 43 notifications in 2007, 26 notifications in 2008 and 19 notifications in 2009.

4.2 PUBLIC HEALTH INFORMATION

Primary aromatic amines

Commission Directive 2002/72/EC lays down general specifications for plastics which states that PAAs should not migrate into food, or to a food simulant in detectable quantities. Some PAAs are considered potential human carcinogens. They can be formed from isocyanates used in glues, adhesives in laminates, and released from azo dyes or azo pigments used as colours. There may also be other sources.

Lead and cadmium from ceramic ware

Council Directive 84/500/EEC lays down migration limits for lead and cadmium from ceramic ware

2 into 4% acetic acid. Commission Directive 2005/31/EC amending the above-mentioned Council Directive requires a declaration of compliance for ceramic articles and appropriate documentation to demonstrate that they comply with the migration limits for lead and cadmium. The manufacturer or the importer into the Community shall make the documentation available to the national CA on request. It shall contain the results of the analyses carried out, the test conditions and the name and address of the laboratory that performed the tests.

Formaldehyde

Directive 2002/72/EC lays down a specific migration limit of 15 mg/kg for formaldehyde, a monomer used to manufacture melamine kitchenware.

DEHA

DEHA is used as a plasticiser in polyvinyl chloride (PVC) cling films and other PVC applications. Directive 2002/72/EC lays down a specific migration limit of 18 mg/kg of food for DEHA. Certain cling films exceeded the migration limit for DEHA, especially into meat.

5 FINDINGS AND CONCLUSIONS

5.1 LEGAL REQUIREMENTS

• Article 3 of Regulation (EC) No 1935/2004 states that materials and articles, including active and intelligent materials, shall be manufactured in compliance with good manufacturing practice (GMP) so that, under normal foreseeable conditions of use, they do not transfer their constituents to food in quantities which could endanger human health or bring about an unacceptable change in the composition of food or a deterioration in the organoleptic characteristics thereof. • Article 16 of the above Regulation states that FCM with specific measures (e.g. Plastics, ceramics) shall be accompanied by a written declaration stating that they comply with the applicable rules. Article 17 of same Regulation establishes traceability requirements in FCM. • Article 2 of Directive 84/500/EEC lays down specific migration limits for lead and cadmium in ceramic. • Article 2 of Directive 2002/72/EC lays down the overall migration limit of constituents from plastics to foodstuffs. In addition, a list of monomers, starting substances and additives authorised to use in plastics and specific migration limits for these constituents is provided in the Annexes to this Directive. Article 9 of the Directive requires that at the marketing stages other than the retail stages, plastic materials and articles which are intended to be placed in contact with foodstuffs shall be accompanied by a written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004. • Regulation (EC) No 2023/2006, in particular Article 4, requires business operators to ensure that manufacturing operations are carried out within the general rules of GMP or detailed 3 rules on GMP as set out in the Annex to this Regulation. • Article 3 of Directive 82/711/EEC requires that compliance with the limits of migration of constituents of plastic materials and articles into foodstuffs shall be verified under the most extreme conditions of time and temperatures foreseeable in actual use, by using food simulants following the basic rules for testing as laid down in the Annex to the Directive. • Annex of Directive 85/572/EEC lays down the list of food simulants to be used for testing the migration of constituents of plastic materials and articles intended to come into contact

3 with foodstuffs.

5.2 COMPETENT AUTHORITIES

Findings There are two CAs responsible for FCM control in Hong Kong. The Centre for Food Safety (CFS) under the FEHD and the Consumer Protection Bureau (CPB) under the C&ED. The FEHD is one of the executive Departments under the (the other two departments are Department of Health and Agriculture, Fisheries and Conservation Department). CFS is one of the three branches under the FEHD and is the branch responsible, among other things for official controls of FCM in food establishments in Hong Kong. CFS has in total 500 staff, approximately 80% of them are involved in enforcement activities. C&ED has in total five branches, of which CPB under the Trade Control Branch is responsible for the official controls of consumer goods supplied for private use or consumption in Hong Kong. According to the Consumer Goods Safety Ordinance from 1995, FCM are considered as consumer goods and are subject for official controls by the CPB. The CPB has in total 35 staff for the official control of consumer goods. The Boundary and Port Branch (BPB) of C&ED is responsible for, inter alia, the customs control of seaborn cargo at the points of import and export, including imports/exports of contraband and prohibited articles. The CAs stated that it is the responsibility of the traders (including both exporters and importers) to ensure that their products, including FCM, comply with the requirements of the importing coountries. The CAs stated that there is no CA designated either for the export control of FCM or controls of FCM transited from mainland China via Hong Kong. The CAs stated that since no specific training on FCM has been organised yet, tasks of both CA, the CFS and CPB, are currently limited to sampling of FCM only. The FEHD stated that 2 staff from this department participated in the EU-China FCM training in Yangijang in April 2008. No training on FCM has been organised for traders of FCM export to the EU. It was stated by the CAs that if such training will be organised in the future then the Hong Kong traders associations will be responsible for the organisation of such trainings for its members. It was stated by the CAs that one of the ways communicating with stakeholders takes place via Trade Consult Forum, which regularly organise meetings with trade associations and industry representatives. Trade Consult Forum is forum initiated by Hong Kong government, its meetings are chaired by the FEHD, which generally takes place once every 2 months. In addition, Consumer Liaison Group, chaired by the FEHD, is also used as a tool to communicate with stakeholders. The mission team noted that neither CAs nor industry representatives met during the mission were aware of the export control procedures in mainland China in particular that consignments trans- shipped to EU via HK have to comply with the Chinese FCM requirements and not with EU requirements. There is no FCM laboratory designated for controls of export for FCM, however the Government Laboratory is the official laboratory designated for FCM analysis for the HK market. In addition, Food Research Laboratory (FRL) of CFS is undertaking FCM analysis in the context of FCM surveys by CFS.

4 Conclusions CAs for official control of FCM marketed and used in Hong Kong are clearly defined. There is no CA designated for the export control of FCM or controls of FCM trans-shipped from mainland China via Hong Kong. No trainings on FCM has been organised yet neither by CAs or Hong Kong traders associations.

5.3 LEGISLATION

Findings There is no specific FCM legislation established in Hong Kong. When necessary, reference to Chinese or international standards is made, mainly to EC or USA standards. The mission team noted in the Government Laboratory visited, that when reference to two different international standards is possible, reference to less stricter standard is made. For example, in 2008 four samples taken by CPB from the market were found to be non-compliant with regard to formaldehyde migration from melamine ladles. Laboratory performed first analysis according to requirements of Commission Directive 2002/72/EC. After non-compliant results were confirmed, CPB asked laboratory to test samples also according to the Chinese standard. At the time of the tests, specific migration limit (SML) for formaldehyde in Chinese standard (GB T 5009-61-2003) was 30 mg/L, while SML set up in Directive 2002/72/EC is 15 mg/kg. The Hong Kong legislation that has some references to the official control of FCM is as follows: • The Consumer Goods Safety Ordinance from 1995, which designates the C&ED as CA for FCM control marketed in Hong Kong and also makes reference to international standards, as described above. • The Public Health and Municipal Services Ordinance and its sub-law Food Business Regulation from 1999, which designates FEHD as CA for FCM control at food establishments. Both laws also among other things establish enforcement powers for the officials of both authorities. The mission team was informed by the CAs that these two above mentioned Ordinances are not applicable for products for export or products transited or trans-shipped from mainland China via Hong Kong. In addition to legislation, some guidelines related to FCM has been elaborated by CFS such as “Guidelines on the use of disposable plastic containers” from 2006 and “Guidelines on the use of Disposable Tray Liners” from 2009. The mission team was informed by the CEDB that EC legislation on FCM has been made available to all stakeholders in the form of circulars issued by the Trade and Industry Department of the CEDB. These circulars are also published on the Trade and Industry Department internet website. The mission team noted that information on the website was up to date and included references to to all latest EC legislation. Conclusions There is no specific FCM legislation in place in Hong Kong and reference to Chinese or international standards is made, when necessary. There is no legal basis for FCM control exported from Hong Kong (including products produced in

5 mainland China). EC legislation on FCM has been made available to all stakeholders via circulars and Trade and Industry Department internet website.

5.4 COMPETENT AUTHORITY CONTROLS

Findings Organisation of controls There are two separate FCM controls organised by the CFS and CPB. The CFS activities regarding FCM are organised in the form of surveys and focus on the issues identified through the FEHD risk assessment and consumer complaints. So far two studies have been conducted: a study on disposable plastic containers for take away meals in 2005 and a study on the food safety of instant cup noodle containers in 2008. A study on safety of melamine kitchenware available in local food premises is currently ongoing. The study on disposable plastic containers was a joint study with Hong Kong Consumer Council and included in total 340 samples for identification of their materials and 30 samples for heavy metals and styrene monomer. According to the CFS all samples were in compliance with the requirements of the relevant United States Food and Drug Administration (US FDA) standards. With regard to a study on the safety of instant cup noodle containers, some 52 samples were taken for identification of their materials and 30 samples for overall migration and styrene monomer testing according to US FDA standard and heavy metals and diaminotoluene migration according to Chinese standards. All samples were in compliance with the requirements of the relevant Chinese standard and USA standards. The CFS stated that additional controls can take place on the basis of consumer complaints. Since 2007, some 11 complaints related to FCM have been received by the CFS (utensils used in food premises and food packaging materials). The CPB conducts FCM sampling on an ad-hoc basis. Samples are usually taken in response to consumer complaints. A control plan is made quarterly. Since January 2008 some 54 FCM samples have been taken, including 27 samples from plastics for the analysis of migration of bisphenol A in baby bottles and migration of formaldehyde and melamine from melamine kitchen ware. However, no analysis for PAAs and phthalates (notified via RASFF) have been conducted. No official controls of such products have been undertaken as there is no any legal basis for official controls for FCM control exported from Hong Kong or transited/trans-shipped from mainland China via Hong Kong. Enforcement The enforcement powers of C&ED are set up in the Consumer Goods Safety Ordinance. These include powers to require the storage of non-compliant or suspect consumer goods under special locations or to prohibit marketing of unsafe goods in Hong Kong. If these orders are not followed, special prosecution procedure is foreseen in the above mentioned Ordinance, which includes among other things written warnings, administrative fines up to 500,000 HKD or imprisonments up to 2 years. The mission team saw evidences on the use of these powers in case of non compliant FCM found on the market (high levels of formaldehyde in melamine kitchen ware from mainland China). However, as there is no legal basis for official controls for FCM control exported from Hong Kong or transited/trans-shipped from mainland China via Hong Kong these enforcement powers are not applicable in case of FCM export or its transited/trans-shipment from mainland China via Hong

6 Kong. As far as FEHD is concerned, enforcement powers are set up in the Public Health and Municipal Services Ordinance. The FEHD stated that as there has no been any non compliant FCM identified during specific studies or during the investigations conducted as a result of consumer complaints, there has been no need to use these powers. The mission team was also informed that all samples are currently analysed in FRL as part of the FEHD risk assessment study. In case non-compliant product is identified, new analysis has to be conducted in the Government Laboratory. Conclusions Activities regarding FCM controls in the domestic market are organised in the form of surveys and focus on the issues identified through the CA risk assessment and consumer complaints. The CAs has adequate legal powers of enforcement regarding FCM marketed in Hong Kong which are defined under Hong Kong legislation.

5.5 TRADE INFORMATION ON FOOD CONTACT MATERIALS PRODUCTION

Findings The CAs stated that there is no any official register of FCM manufacturers in Hong Kong. However, during the meeting with industry associations, the Hong Kong Exporters Association stated that there is no FCM manufacture in Hong Kong for EU export, as all major FCM manufacturers are now based in mainland China. This information was also confirmed by the representatives of the private laboratory visited and during the meetings with FCM traders. According to the Trade and Industry Department of CEDB the volume of Hong Kong FCM exports is as follows: Year Total value of FCM export (HKD) Value of FCM export into the EU (HKD) 2006 47,1 million 5,9 million 2007 42,8 million 6,2 million 2008 40,8 million 6,2 million

Conclusions

According to the Hong Kong Exporters Association t here is no FCM manufactured in Hong Kong exported into the EU, however no any written evidence to confirm this statement was provided to the mission team by the CAs.

5.6 EXPORT PROCEDURES

Findings The BPB of the C&ED is the CA for the export/import control in Hong Kong including contraband and prohibited articles. According to the CA, the vast majority of FCM exported into EU by Hong Kong companies are either directly shipped from mainland China or trans-shipped from mainland China via Hong Kong. It was stated by the industry associations, that in case of direct shipment from mainland China, Hong Kong traders are mainly used as a shipping agents. According to the

7 CPB, 70% of the RASFF notified products from China, which were exported into EU via Hong Kong, were directly shipped from mainland China, while only 30% of the consignments actually passed Hong Kong territory. According to the BPB t here are 3 trans-shipment possibilities for FCM from mainland China: already containerised products pass through Hong Kong either by road or boat; FCM is imported and containerised in traders warehouse in Hong Kong or the product is imported and containerised at the port. In addition, another trans-shipment option, so called “river trade”, is also used, where already containerised products are transported from mainland China on small boats and loaded on to bigger container boats in specially designated areas outside Hong Kong container port. According to the BPB , the “river trade” option is the main trans-shipment option used for FCM export from mainland China. The CA stated that when consignments are trans-shipped from mainland China via Hong Kong the BPB is not notified of products passing through Hong Kong, as advanced cargo information is not legally obligatory. According to the BPB , in some 30% cases BPB receives advanced cargo information. According to the Hong Kong customs legislation, customs declaration has to be launched within 14 days after the arrival or departure of the vessel, however CN codes are not used in the customs declaration as no import/export tariffs are applied for vast majority of products, including FCM. BPB has the right to select any cargo for further controls, if necessary. In this case, cargo selection is made by using daily shipping information from Vessel Traffic management System and an advanced manifest from shipping agent is requested. However, so far no FCM exported into the EU has been covered by these controls as there is no legislation in Hong Kong to control the export and trans-shipment of FCM and therefore priority is given to imports into the Hong Kong. The CA stated that when non-compliant goods are returned from Europe to Hong Kong these are usually further shipped to mainland China. In this case Chinese CA, the AQSIQ, is notified by C&ED. The mission team saw evidences of such communication. According to the CAs. So far only one request has been received by the CPB to authorise such product to be sold on the local market. Conclusions The vast majority of FCM manufactured in China and exported into EU by Hong Kong traders are directly shipped from mainland China without actually passing Hong Kong territory. When consignments are trans-shipped from mainland China via Hong Kong the BPB is not notified of products passing through Hong Kong and therefore no export control of FCM takes place. Non-compliant goods, when returned from Europe to Hong Kong, are usually further shipped to mainland China.

5.7 RESPONSE TO RASFF NOTIFICATIONS

Findings The FEHD is the RASFF contact point in HK. As far as FCM is concerned CPB is responsible for follow-up. According to CPB some 119 notifications related to FCM have been followed up since 2004. The mission team noted that 2 notifications from 2004, 4 notifications in 2006, 13 notifications in 2007, 6 notifications from 2008 and 2 notifications from 2009 have not been followed up and no investigation was undertaken. The mission team observed that investigation to the RASFF notifications focused on ensuring that products do not enter into the Hong Kong market. According to the CPB investigations, the vast

8 majority of the goods were already destroyed abroad, while in 6 cases goods were returned and destroyed in Hong Kong, in six cases goods were returned back to mainland China via Hong Kong and in one case permission was granted to market returned goods in Hong Kong. The CA stated that despite the fact that all notifications were related to products from mainland China, the outcome of the investigation was notified to the AQSIQ or Chinese FCM manufacturers only in two cases, when Hong Kong CA notified AQSIQ of the disposal of goods shipped back from EU to mainland China. Conclusions There are procedures in place for the communication and investigation of RASFF notifications in Hong Kong, however not all RASFF notifications have been investigated.

There is a very limited communication between Hong Kong CAs and AQSIQ with regard to the outcome of the RASFF investigations by CPB when a FCM product is manufactured in mainland China.

5.8 OFFICIAL CONTROL LABORATORY SERVICES

Findings General Organisation There are 1 official laboratory, 1 research laboratory and at least 5 private laboratories available in Hong Kong for FCM analysis. The mission team visited the Government Laboratory, the Food Research Laboratory (FRL) and 1 private laboratory. The Government Laboratory The Government Laboratory is a department within the Food and Health Bureau. The test samples for FCM are provided by the CPB. The samples provided are enforcement samples and are tested according to the legislation/standard specified by the CPB. Testing is carried out on materials and articles that are sold for use by Hong Kong consumers. The laboratory has 21 staff of which 1 chemist and 4 technicians are involved in FCM testing. Over the period January 2008 to August 2009 54 FCM samples were tested (some 1500 samples per year are tested by the laboratory therefore FCM testing is only a small percentage of the laboratories activity). Of these bisphenol A, melamine and formaldehyde were tested to EU standards. For the melamineware testing the choices of simulant and test conditions were in accordance with the EU legislation. For bisphenol A the standard method applied was not always the EN13130 standard but on occasions EN14350-2 was followed. The mission team was informed that to demonstrate that FCM is in line with EU legislation the EN13130 series of standards has priority. If a sample fails the EU test it may then be re-submitted by CPB to test according to the mainland China GB standard. They are accredited by HKAS to ISO 17025 for heavy metals analysis from ceramics but not for the methods carried out according to the EU standards. The laboratory only seeks accreditation for routine methods (as was previously the case for ceramics). Other methods current used to test FCMs are not accredited. Instead Internal Quality Control procedures based on HKAS requirements are followed. The quality control parameters are written out as an SOP and are appropriate for the implementation of the international standards used. The laboratory has not participated in any proficiency test (PT) schemes on FCMs. Examples of test reports and supporting data were observed for polypropylene containers and melamine ladles.

9 The data generated was traceable to sample receipt, data checking procedures were in place and the appropriate quality control samples were analysed in each batch. To date the laboratory has not been asked to test for PAA migration from nylon articles. However, the laboratory do have the necessary analytical equipment and qualified personnel to carry out this analysis. The Food Research Laboratory The FRL is part of the Risk Assessment and Communications Division of the CFS. The FRL consists of 23 members of staff. There is a unit with 1 chemist and 4 technicians, where deployment is made whenever FCM study is being conducted. Staff are trained to carry out the work and the chemist working in this area (qualified to PhD level) showed a comprehensive understanding of method development, validation and data interpretation. Laboratory work on FCMs involves testing materials and articles used in food serving establishments in Hong Kong. In general, laboratory generate data to facilitate risk assessments rather than to test compliance with legislative limits and they implement their methods accordingly. Due to the changing nature of their work methods for FCMs are not accredited. Internal Quality Control procedures were presented to the mission team that are based on Hong Kong Accreditation Service (HKAS) requirements. The laboratory does not participate in any proficiency testing (PT) schemes due to a lack of available resource. As far as FCM analysis concern, laboratory has tested disposable plastic containers for take-away meals and instant cup noodle containers following mainland China and US-FDA methods. A test report for the instant cup noodle study was provided which included advice to consumers and the traders. The outcomes of their studies are presented in the form of scientific test reports as well as Guidelines for FCM users and consumers (article in Consumer Council magazine). An ongoing study is looking at migration of melamine and formaldehyde from melamineware articles according to EU Directives and EN standards as well as the mainland China GB standards. The selection of the food simulant and test conditions was appropriate for the EU legislation. The analytical procedure described for the determination of the formaldehyde was an in-house method. The validation data assessed was fit for purpose. The laboratory has not performed any PAA analysis to date however they have the analytical equipment to do so. The laboratory is not involved in analysis of enforcement samples themselves but if any unacceptable products were identified in their research studies they would inform the CPB who would take an official sample for analysis by the Government Laboratory. Private laboratory The private laboratory visited carries out among other analysis analytical testing for FCM manufacturers. Manufacturers are generally based in mainland China and may send samples directly to the laboratory. The laboratory tests between 600 and 1500 FCM samples a month with most manufacturers sending samples for testing on a yearly basis. Staff are trained to carry out the work and are their training records are only signed off after competence has been demonstrated. The chemist describing the FCM activities showed a thorough understanding of method development, validation and data interpretation. The laboratory is accredited by HKAS to ISO 17025 for heavy metal analysis from ceramics and for overall migration to EU standards. Accreditation for melamineware is quoted to US standards and they are currently extending the accreditation for PAAs but only for the spectrophotometric

10 determination of the total PAAs. The laboratory does have the necessary analytical equipment to determine the specific PAAs and they are accredited for the determination of specific PAAs in textiles. The laboratory participates in PT schemes and organises internal inter-laboratory comparison studies for the network of its more than 300 laboratories. The laboratory has a separate Quality Management section which carries out internal audits in addition to the HKAS external audits. Other laboratories Four other private laboratories were identified as being accredited for FCM testing through the HKAS website. Conclusions The official laboratory visited was accredited to ISO 17025, sufficiently equipped and staffed to conduct migration testing to EC standards, however the current scope of accreditation cover only very limited number of analytical methods for FCM analysis. There are sufficient number of FCM laboratories at the disposal of FCM manufacturers and traders to conduct migration testing to EC standards. However, they are not used for export control purposes. The analytical methodology of visited laboratories did not cover the main substances notified through the RASFF (PAAs). The methods of analysis of melamineware implemented by the laboratories were in line with the EU requirements.

6 OVERALL CONCLUSIONS

The Hong Kong authorities have no legal basis for FCM control transited from mainland China via Hong Kong into EU even though these products are not controlled to EU standards in China. Given the current status it is not possible for Hong Kong authorities to implement export controls.

7 CLOSING MEETING

A closing meeting was held on 3 December 2009 with the competent authorities, FEDB and C&ED. Representatives of the CEDP and Government Laboratory were also present. At this meeting, the main findings and conclusions of the mission were presented by the mission team.

8 RECOMMENDATIONS

An action plan in response to the recommendations should be forwarded to the Commission within 25 days of receipt of the report. This action plan should clearly set out the manner and deadline by which the competent authorities will address each of the following recommendations: N°. Recommendation

1. Ensure that FCM exported into EU via Hong Kong comply with the requirements at least equivalent to Commission Directive 2002/72/EC.

2. Consider informing the CAs of mainland China regarding the outcome of the investigation of RASFF notifications related to FCM exported into EU from mainland

11 N°. Recommendation

China via Hong Kong.

3. Consider initiating training and awareness campaigns to ensure that Hong Kong traders exporting FCM into EU are aware of the provisions set down in EU FCM legislation.

The competent authority's response to the recommendations can be found at:

http://ec.europa.eu/food/fvo/ap/ap_hk_2009-8158.pdf

12 ANNEX 1 - LEGAL REFERENCES

Legal Reference Official Journal Title

Reg. 882/2004 OJ L 165, 30.4.2004, Regulation (EC) No 882/2004 of the European p. 1, Corrected and Parliament and of the Council of 29 April 2004 on re-published in OJ L official controls performed to ensure the 191, 28.5.2004, p. 1 verification of compliance with feed and food law, animal health and animal welfare rules

Reg. 178/2002 OJ L 31, 1.2.2002, p. Regulation (EC) No 178/2002 of the European 1-24 Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

Reg. 1935/2004 OJ L 338, 13.11.2004, Regulation (EC) No 1935/2004 of the European p. 4-17 Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC

Reg. 2023/2006 OJ L 384, 29.12.2006, Commission Regulation (EC) No 2023/2006 of 22 p. 7578 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food

Reg. 282/2008 OJ L 86, 28.3.2008, p. Commission Regulation (EC) No 282/2008 of 27 9-18 March 2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 2023/2006

Dir. 84/500/EEC OJ L 277, 20.10.1984, Council Directive 84/500/EEC of 15 October 1984 p. 12-16 on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs

Dir. 2002/72/EC OJ L 220, 15.8.2002, Commission Directive 2002/72/EC of 6 August p. 18-58 2002 relating to plastic materials and articles intended to come into contact with foodstuffs

Reg. 372/2007 OJ L 92, 3.4.2007, p. Commission Regulation (EC) No 372/2007 of 2 9-12 April 2007 laying down transitional migration limits for plasticisers in gaskets in lids intended to

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come into contact with foods

Dir. 82/711/EEC OJ L 297, 23.10.1982, Council Directive 82/711/EEC of 18 October 1982 p. 26-30 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs

Dir. 85/572/EEC OJ L 372, 31.12.1985, Council Directive 85/572/EEC of 19 December p. 14-21 1985 laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs

Dir. 78/142/EEC OJ L 44, 15.2.1978, p. Council Directive 78/142/EEC of 30 January 1978 15-17 on the approximation of the laws of the Member States relating to materials and articles which contain vinyl chloride monomer and are intended to come into contact with foodstuffs

Dir. 80/766/EEC OJ L 213, 16.8.1980, Commission Directive 80/766/EEC of 8 July 1980 p. 42-46 laying down the Community method of analysis for the official control of the vinyl chloride monomer level in materials and articles which are intended to come into contact with foodstuffs

Dir. 93/11/EEC OJ L 93, 17.4.1993, p. Commission Directive 93/11/EEC of 15 March 37-38 1993 concerning the release of the N-nitrosamines and N- nitrosatable substances from elastomer or rubber teats and soothers

Dir. 81/432/EEC OJ L 167, 24.6.1981, Commission Directive 81/432/EEC of 29 April p. 6-11 1981 laying down the Community method of analysis for the official control of vinyl chloride released by materials and articles into foodstuffs

Reg. 1895/2005 OJ L 302, 19.11.2005, Commission Regulation (EC) No 1895/2005 of 18 p. 28-32 November 2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food

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