STC Number - 430

EU maximum level of cadmium in foodstuffs

Maintained by: European Union
Raised by: Colombia; Côte d'Ivoire; Ecuador; Madagascar; Peru
Supported by: Bolivia, Plurinational State of; Brazil; Costa Rica; Dominican Republic; El Salvador; Ghana; Guatemala; Indonesia; Nicaragua; Nigeria; Panama; Trinidad and Tobago; United States of America
First date raised: November 2017 G/SPS/R/88, paras. 3.8-3.10
Dates subsequently raised: March 2018 (G/SPS/R/90, paras. 3.15-3.17)
July 2018 (G/SPS/R/92/Rev.1, paras. 4.31-4.33, 4.73-4.78)
November 2018 (G/SPS/R/93, paras. 3.31-3.37)
Number of times subsequently raised: 3
Relevant documents: G/SPS/GEN/1587; G/SPS/GEN/1624; G/SPS/GEN/1646
Products covered: 18 Cocoa and cocoa preparations

chocolates and other cocoa products
Primary subject keyword: Food safety
Keywords: Human health; Maximum residue limits (MRLs); Appropriate level of protection; International Standards / Harmonization; Food safety
Status: Not reported
Solution:
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In November 2017, Peru raised a concern over the maximum levels of cadmium in chocolates and other cocoa products proposed by the European Union Commission Regulation (EU) No. 488/2014, which would come into force in January 2019. Peru highlighted that it was the second largest exporter of cocoa after Ecuador, and emphasized the importance of cocoa and chocolate exports to its economy. Peru queried whether the measure was based on "as low as reasonably achievable" (ALARA) principles. The risk analysis for substances of this kind should be conducted using the margin of exposure (MOE) approach. Peru reported that the Codex Committee on Contaminants in Food was developing a Codex standard on maximum levels of cadmium in chocolate and other cocoa products, and was expected to publish it in 2019. Peru submitted further details in document G/SPS/GEN/1587.

Colombia, Costa Rica, Côte d'Ivoire, the Dominican Republic, Ghana, Guatemala, Madagascar, and Nigeria shared Peru's concerns and requested that the European Union consider delaying the implementation of this measure until Codex had developed relevant international standards, or to exclude chocolates from the scope of application of the measure. Colombia also requested assistance to mitigate the trade impact of this measure along with a longer transition period, taking into account the needs of developing country Members. Costa Rica added that intrinsic difficulties in controlling the level of cadmium in cocoa production be taken into account when setting these levels. The ECOWAS representative indicated that ECOWAS members also shared the concern.

The European Union highlighted its efforts to alleviate the difficulties of trading partners in complying with this measure, such as agreeing to a transitional period of five years in October 2012, which had deferred the application date to January 2019, and setting maximum limits for blended products instead of cocoa beans to facilitate trade. The European Union further elaborated that these limits were based on EFSA recommendations that exposure to cadmium should be reduced and that in the light of available science, excluding chocolate and cocoa products from this measure would not achieve the desired level of protection.

In March 2018, Peru reiterated its concern over the maximum levels of cadmium in chocolates and other cocoa products proposed by the European Union Commission Regulation (EU) No. 488/2014. Peru highlighted the social and economic importance of cocoa and chocolate exports to its economy, underscoring the potential negative impact of the regulation on its exports. Peru further observed that the regulation did not establish maximum levels for cadmium in cocoa beans, only in chocolate. Peru recalled the findings of the European Food Safety Authority (EFSA), which indicated that it was unlikely that there would be adverse effects in an individual exposed to dietary cadmium in the European Union. Peru also noted that JECFA considered foods to be a risk when it contributed 5% or more of the maximum tolerable daily intake of the contaminant. Based on the JECFA parameter, Peru argued there was no justification for including chocolate in the regulation, as it only contributed 4.3% to dietary cadmium exposure, and further concluded that the EU regulation was not in line with the SPS Agreement. Peru drew Members' attention to the ongoing development of a Codex standard for cadmium maximum levels and highlighted that this standard could serve as a reference point for trade. Finally, Peru urged the European Union to exclude chocolate and cocoa products from the scope of its regulation.

Brazil, Colombia, Costa Rica, the Dominican Republic, Guatemala, and Panama shared Peru's concern, and requested that the European Union exclude chocolate and cocoa products from its regulation pending the development of Codex standards on maximum levels of cadmium.

The European Union recalled its intervention in the November 2017 Committee meeting, highlighting that the measure was based on EFSA recommendations that exposure to cadmium should be reduced, and that in light of available science, excluding chocolate and cocoa products from this measure would not achieve the desired level of protection. The EFSA assessment had taken into consideration EU consumption patterns. In addition, the European Union was of the view that the exposure assessment undertaken by JECFA gave no basis for amending the EU maximum levels for cadmium. The European Union reminded Members of its efforts to alleviate the difficulties of trading partners in complying with this measure, such as agreeing to a transitional period of five years, which had deferred the application date to January 2019, and setting maximum limits for blended products instead of cocoa beans to facilitate trade. The European Union further noted its active participation in Codex discussions on establishing an international standard for cadmium maximum levels.

In July 2018, Ecuador raised a concern on the private application of Regulation (EU) No. 488/2014, modifying a previous regulation on maximum levels of cadmium in foodstuffs (including chocolate and certain cocoa based products). Although the implementation of the measure had been scheduled to take place as of 1 January 2019, Ecuadorian exporters had been reporting that EU importers seemed to be applying it already and incorrectly, that is, not to the finished products (chocolates and certain cocoa-based products) as provided in the measure, but to the input material (cocoa beans). Ecuador explained that while this was not a private standard, it referred to the incorrect application by private entities of Regulation (EU) No. 488/2014. Therefore, Ecuador requested the European Union to offer the necessary monitoring guarantees to ensure the proper application of this Regulation, to avoid an unnecessary barrier to trade, much more burdensome that what the Regulation provided for, even prior to its official implementation. Finally, Ecuador expressed its willingness to the share the reports from its exporters with the European Union.

Colombia expressed its interest in the topic and provided further details under STC No. 430, with which this concern was related. Guatemala also shared the concern.

The European Union underlined its understanding and sympathy towards Ecuador's concern. EU Regulation (EU) No. 488/2014 established maximum levels of cadmium for finished products directly sold to consumers, and did not apply to cocoa beans or intermediate cocoa products, which were the products exported from Latin America to the European Union. The European Union reminded Members of the exceptionally long transitional period of five years exclusively granted for cocoa and chocolate products, until 1 January 2019. Private operators applied cadmium limits to imported cocoa beans instead of to finished products, without respecting the transitional period of five years granted by the Regulation, which was incorrect and not in line with the Regulation. However, the European Union considered that this concern went beyond the scope SPS Agreement. In this regard, the European Union pointed out that the concern focused on actions of commercial operators, over whom official authorities from the European Union did not have jurisdiction. The European Union believed that this concern should be raised in other fora, such as the International Cocoa Organization. In the area of technical assistance, there was an on-going STDF project preparation grant to develop regional strategies and a project proposal to establish mitigation and remediation methods for cadmium contamination in cocoa beans in Latin America and the Caribbean, specifically targeted to assist in complying with EU requirements. In addition, the recently launched EU initiative Development-Smart Innovation through Research in Agriculture (DeSIRA) included two proposals on climate-relevant innovation for sustainable cocoa production, with activities related to cadmium. The European Union explained that these two projects were scheduled to start during 2019 and would focus on Colombia, Côte d'Ivoire, Ecuador and Peru.

Peru reiterated its concern over the maximum levels of cadmium in chocolates and other cocoa products proposed by Regulation (EU) No. 488/2014, highlighting the potential negative impact on trade of cocoa beans with the European Union and other international markets. Peru highlighted that JECFA, at its 77th meeting, had not considered the contribution of products containing cocoa or cocoa products to total cadmium dietary exposure for high consumers of such products to be of concern. The EU Regulation, which was based on a hazard approach, had set a very low maximum level of cadmium in chocolate and other cocoa products. Peru observed that the entry into force of the regulation on 1 January 2019 would harm Peruvian cocoa producers and exporters, and many other WTO Members, as well as undermine alternative development farming programmes being implemented with the help of international partners, such as the European Union. Peru reiterated its request for the European Union to exclude chocolate and other cocoa products from the scope of its regulation until there was updated scientific information regarding the level of risk to human health from cadmium. If the consideration of this request was not possible, Peru further urged the European Union to extend the entry into force of the regulation to 1 January 2022, pending the adoption of Codex maximum levels of cadmium.

Colombia echoed Peru's concerns on this issue, also highlighting the significant economic and social impact to its cocoa sector. Colombia outlined its national agricultural policy for cocoa cultivation that sought to replace illegal products by incentivizing producers to change their crops, which was supported by the European Union and other WTO Members. Colombia remained concerned that the results of these efforts could be undermined due to the regulation. Colombia further highlighted other national and international initiatives to address the issue of cadmium, including an STDF-funded project for Latin America and the Caribbean. In accordance with Article 10 of the SPS Agreement, Colombia requested a longer transition time-frame for the implementation of the regulation and urged the European Union to consider excluding chocolate from the scope of its regulation, bearing in mind that there were no Codex maximum levels for cadmium in chocolate. Colombia also requested the European Union to provide additional resources to continue their research on cadmium in cocoa and to implement the necessary mitigation measures.

Madagascar supported the concerns raised and requested the European Union to consider a new transitional period for the implementation of Regulation (EU) No. 488/2014. This would give Codex the time to finalize and publish their ongoing work on the definition of maximum levels of cadmium in chocolate and cocoa products. In addition, it would allow countries exporting to the European Union time to adjust to the new regulatory standards. Madagascar further emphasized that the current date for adoption of the regulation (i.e. 1 January 2019), would have a significant economic impact on its producers.

Brazil, Costa Rica, Ecuador, Ghana, Guatemala, Nicaragua, Nigeria, Panama, and Trinidad and Tobago shared the concerns, and requested that the European Union exclude chocolate and cocoa products from its regulation and/or postpone the implementation of the regulation until the development of Codex standards on maximum levels of cadmium. Indonesia and the United States also echoed the concerns and urged the European Union to set its maximum levels in accordance with scientific evidence. Trinidad and Tobago further noted the research conducted on the mitigation of cadmium bioaccumulation in cocoa beans, which had showed encouraging results with respect to the use of genetic and soil enhancement strategies. However, Trinidad and Tobago also highlighted that mitigation methods were constrained by their costs and the timing of the results, which further underscored the negative impact that the proposed regulation would have on the international market price for cocoa beans and overall cocoa bean trade.

Codex informed the Committee that two maximum levels for cadmium had already been adopted at the Commission's meeting held the previous week, one had been discontinued due to lack of data, and that Codex would continue work on two other maximum levels. Codex also informed the Committee that Peru had noted its reservation on the adoption of the two maximum levels as it considered the levels too strict.

The European Union recalled its previous interventions, highlighting that the limits in Regulation (EU) No. 488/2014 were based on risk assessments and scientific opinions from EFSA, which clearly concluded that cadmium exposure should be reduced and that certain population subgroups already exceeded the tolerable weekly intake. The European Union thanked Codex for the information provided and noted that the EU limits for chocolate containing a high amount of cocoa (>50%) were consistent with the adopted Codex maximum levels. The European Union reminded Members of its efforts to alleviate the difficulties of trading partners in complying with this measure, such as agreeing to a transitional period of five years, which had deferred the application date to January 2019, and setting maximum levels for blended products instead of cocoa beans to facilitate trade. The European Union further explained that this health protection measure could not be delayed any longer. In relation to technical assistance, the European Union recalled the STDF project, among other initiatives, to mitigate the impact of the measure. Regarding problems with importers, the European Union referred to its previous statements. The European Union remained open to bilateral discussions with Members.

In November 2018, Peru reiterated its concern over the maximum levels of cadmium in chocolates and other cocoa products proposed by Regulation (EU) No. 488/2014, and observed that the entry into force of the regulation on 1 January 2019 would have a negative impact on trade of cocoa beans with the European Union. According to Peru, the new maximum levels of cadmium were not justified by scientific evidence (G/SPS/GEN/1646). JECFA considered a food to represent a risk when it contributed 5% or more of the maximum tolerable intake of the contaminant, and since chocolate and cocoa products contributed only 4.3% to dietary cadmium exposure, there were no grounds for including them in the regulation. Peru also noted inconsistencies in the EU Regulation, which established the same maximum levels of cadmium, 0.10 mg/kg, for potatoes and chocolate with up to 30% cocoa, in spite of the fact that potatoes contributed a much higher percentage than chocolate (13.2%) to overall cadmium dietary exposure, and had a different consumption pattern. Therefore, the EU Regulation was in violation of articles 2.2, 2.3, 5.1 and 5.4 of the SPS Agreement, since it was not based on scientific principles, no proper risk assessment had been conducted, and the objective of minimizing the negative effects on trade when determining the appropriate level of sanitary protection had not been considered. The entry into force of the regulation would harm Peruvian cocoa bean producers, and many other WTO Members, as well as undermine Peru's joint efforts with the international community, including the United States and the European Union, to combat illicit drug trafficking within the framework of comprehensive and sustainable programmes for the development of alternatives to coca leaf production. Peru reiterated its request for the European Union to exclude chocolate and chocolate products from the scope of its regulation until there was updated scientific evidence on the level of risk to human health from cadmium, and Codex would finalize the adoption of maximum levels for cocoa. Peru concluded by requesting the European Union to postpone the entry into force of the regulation to 1 January 2022.

Côte d'Ivoire echoed Peru's concerns on this issue, and explained that efforts were being currently undertaken in the country to diversify exports and increase the production of higher value processed products. The entry into force of the EU Regulation, not based on a risk assessment, would negatively impact on exports of cocoa products, allowing trade in cocoa beans only, which was more sensitive to price fluctuations. While Côte d'Ivoire recognized the legitimate right of the European Union to take measures to protect its population, it urged the European Union to review its Regulation until the adoption of Codex maximum levels for cadmium in chocolate.

Colombia reiterated its concern over the proposed Regulation (EU) No. 488/2014, highlighting again the significant economic and social impact on the cocoa sector. Colombia recalled that its national agriculture policy aimed to replace illicit crops by incentivizing producers to change poppy and coca crops by seeding cacao. As a result, cultivation and exports of cocoa to the European Union had increased. Colombia remained concerned that the positive results obtained with the support of international cooperation initiatives, including the WTO through the STDF, and EU funding, would be affected by the application of the EU Regulation. In accordance with Article 10 of the SPS Agreement, Colombia requested the European Union to provide additional resources to continue research on cadmium in cocoa and to implement the necessary mitigation measures. Also, referring to JECFA's scientific opinion and Article 3 of the SPS Agreement, Colombia requested the exclusion of chocolate from the scope of the regulation. Finally, Colombia invited the European Union to consider notifying draft SPS legislation at an earlier stage, so as to allow sufficient time for comments to be considered.

The Plurinational State of Bolivia, Ecuador, Guatemala, Indonesia, Nicaragua, and Trinidad and Tobago shared the concerns, and requested that the European Union exclude chocolate and cocoa products from the scope of its regulation and/or to extend the entry into force of the regulation to 1 January 2022, pending the development of Codex standards on maximum levels of cadmium. Ecuador highlighted that certain trade operators applied the regulation before its entry into force and incorrectly, that is, not to the finished products as provided in the measure, but to the raw material (cocoa beans). This issue had resulted in the development of a national agenda for cadmium reduction, involving the public and private sectors, to implement mitigation activities, which would require additional resources and time. Trinidad and Tobago highlighted the negative impact of the proposed regulation on diversification initiatives in the cocoa sector.

El Salvador, Panama, the United States, and the Bolivarian Republic of Venezuela also echoed the concerns, emphasizing that the regulation created unnecessary barriers to trade. Furthermore, the United States urged the European Union to consider the objective of minimizing negative trade effects and to ensure that the level of protection achieved by its measure would be scientifically justified.

Costa Rica expressed its systemic interest in this concern, and reminded Members that cadmium, being present in the soil, was present naturally in cocoa. Costa Rica asked the European Union to take this element into consideration in its research on this matter.

The European Union recalled its previous interventions, highlighting that the limits in Regulation (EU) No. 488/2014 were not based on a hazard-based approach, but on risk assessments and scientific opinions from EFSA. Furthermore, the European Union noted that the EU limits for chocolate containing a high amount of cocoa (>50%) were consistent with adopted Codex maximum levels. The European Union reminded Members of its efforts to alleviate the difficulties of trading partners in complying with this measure, such as agreeing to a transitional period of five years. The European Union also pointed out that the ultimate goal of the European Union was to protect the health of EU consumers, and explained that EFSA's risk assessment showed that taking into account the EU Tolerable Weekly Intake (TWI) and consumption patterns, the mean dietary exposure to cadmium in EU countries was close to or slightly exceeded the TWI. The European Union further noted that certain subgroups of the population (mainly children) may even exceed the TWI by about two-fold. Furthermore, based on the risk assessment, it was considered necessary to limit the exposure of EU consumers to cadmium for all commodities, including chocolate. EU maximum levels were set on the basis of occurrence data at a level which was as low as reasonably achievable, and this was 0.10 mg/kg for potatoes and for milk chocolate containing less than 30% total dry cocoa solids. Finally, the European Union informed the Committee on future technical assistance projects on low cadmium and climate relevant innovation to promote sustainable cocoa production in Colombia, Ecuador and Peru.