STC Number - 295

Artificial colour warning labels

Maintained by: European Union
Raised by: United States of America
Supported by: Mexico; New Zealand
First date raised: March 2010 G/SPS/R/58, paras.28-30
Dates subsequently raised: June 2010 (G/SPS/R/59, paras. 45-47)
October 2010 (G/SPS/R/61, paras. 39-40)
Number of times subsequently raised: 2
Relevant documents: G/SPS/N/EEC/291 + Add.1
Products covered: 1704 Sugar confectionery (including white chocolate), not containing cocoa.; 2009 Fruit juices (including grape must) and vegetable juices, unfermented and not containing added spirit, whether or not containing added sugar or other sweetening matter.; 2106 Food preparations not elsewhere specified or included.; 2202 Waters, including mineral waters and aerated waters, containing added sugar or other sweetening matter or flavoured, and other non-alcoholic beverages, not including fruit or vegetable juices of heading 20.09.; 170410 - Chewing gum, whether or not sugar-coated; 170490 - Other
Primary subject keyword: Food safety
Keywords: Food safety; Human health
Status: Not reported
Solution:
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In March 2010, the United States raised concerns about EU Regulation (EC) 1333/2008 on food additives. Article 24 of the Regulation required warning statements on food products that contained one or more of six colour additives: Sunset Yellow (E110), Quinoline Yellow (E104), Carmoisine (E122), Allura Red (E129), Tartrazine (E102), and Ponceau 4R (E124). The United States was particularly concerned with the scientific basis of the regulation, its potential negative impact on international trade, and the transparency of its adoption. Most of these six colour additives were widely used by the food industry in products such as confectionaries and beverages. When the regulation was notified to the WTO Secretariat (G/SPS/N/EEC/291), it did not contain the provision on warning statements, and the United States was not aware of an addendum to the original notification. Statistics from the University of Southhampton and the European Food Safety Authority (EFSA) did not substantiate a link between the individual colours and possible behavioural effects in infants. The United States was also concerned that the European Union planned to implement the measure in July 2010.
New Zealand and Mexico supported the concerns raised by the United States, noting that the measure did not seem to be based on scientific evidence.
The European Union stressed that the issue of colorants was complex and delicate matter, especially in confectionary and beverages consumed by children and infants. The identified additives raised concerns related to health problems in children, such as hyperactivity, attention loss, and deficit-disorder. The study by the University of Southhampton raised concerns and media interest, which led shops and retailers to phase out the sale of products containing those food additives. The new EU regulatory regime on additives and colorants was not an import ban but only introduced certain specific labelling provisions. An opinion from EFSA concluded that although the changes noticed in children behaviour were small, they were statistically significant. The European Union also clarified that an addendum to the original notification had been submitted to the WTO Secretariat (G/SPS/N/EEC/291/Add.1). The new measure allowed for an 18-month transitional period before entering into force. The measure was not discriminatory, since it is applied equally to European producers and imports from third countries.
In June 2010, the United States reiterated concerns about EC Regulation 1333/2008 on food additives. Article 24 of the Regulation required warning statements on food products that contained one or more of six colour additives: Sunset Yellow (E110), Quinoline Yellow (E104), Carmoisine (E122), Allura Red (E129), Tartrazine (E102), and Ponceau 4R (E124). The United States was particularly concerned with the scientific basis of the regulation, its potential negative impact on international trade, and the transparency of its adoption. Most of these six colour additives were widely used by the food industry in products such as confectionaries and beverages. When the draft regulation was notified to the WTO (G/SPS/N/EEC/291), it did not contain the provision on warning statements, and the United States was not aware of an addendum to the original notification. Scientific evaluations from the University of Southampton in 2007 and the European Food Safety Authority (EFSA) in 2009 did not substantiate a link between the individual colours and possible behavioural effects in children. The United States was also concerned that even though EFSA was unable to substantiate a link, the European Union planned to implement the measure in July 2010. The United States had recently petitioned the European Union to delay implementation and would shortly provide the European Union with more than 580 studies to warrant a thorough scientific review of relevant evidence.
New Zealand and Mexico supported the concerns raised by the United States, noting that the EU measure did not seem to be based on scientific evidence.
The European Union clarified that the labelling requirement had been adopted in December 2008 and included a transitional period of 18 months for implementation, which would expire on 20 July 2010, allowing industry time to comply. This measure had been notified by the European Union as a draft on 10 August 2006 (G/SPS/N/EEC/291) and as an addendum with the final text on 2 July 2009 (G/SPS/N/EEC/291/Add.1). A 2007 study by the University of Southampton had concluded that exposure to some mixtures of colorants resulted in increased hyperactivity in 3-year old and 8- to 9-year old children. The new EU regulatory regime on artificial colorants was not an import ban but only introduced certain specific labelling provisions. An opinion from EFSA had concluded that although the changes noticed in children's behaviour were small, they were statistically significant. Until new elements demonstrated the absence of those effects, the European Union's position would remain unchanged. The European Union encouraged the United States to share any additional scientific data as it became available.
In October 2010, the United States reiterated its concerns about EC Regulation 1333/2008 on food additives. Article 24 of the Regulation required warning statements on food products that contained one or more of six colour additives: Sunset Yellow (E110), Quinoline Yellow (E104), Carmoisine (E122), Allura Red (E129), Tartrazine (E102), and Ponceau 4R (E124). The United States continued to be concerned with the scientific basis of the regulation, its potential negative impact on international trade, and the transparency of its adoption. Most of these six colour additives were widely used by the food industry in products such as confectionaries and beverages. When the draft regulation was notified to the WTO (G/SPS/N/EEC/291), it did not contain the provision on warning statements, and the United States was not aware of an addendum to the original notification. Scientific evaluations from the University of Southampton in 2007 and the European Food Safety Authority (EFSA) in 2009 did not substantiate a link between the individual colours and possible behavioural effects in children. The United States was also concerned that even though EFSA was unable to substantiate a link, the European Union implemented the measure in July 2010, disregarding available pertinent information from relevant international organizations, such as the Joint FAO/WHO Expert Committee on Food Additives. The United States requested information from the European Union on any further expansion of the list of additives to be subjected to the warning labels.
The European Union clarified that the new EU regulatory regime on artificial colorants used in food products was not an import ban but only introduced certain specific labelling provisions. The labelling requirements had entered into force in July 2010 and had not shown any noticeable effect on trade. A transitional period of 18 months for implementation had been provided, allowing industry time to comply. The European Union would continue the evaluation, through EFSA, of all food additives to avoid any unnecessary trade disruption. The representative of the European union pointed out that at its March 2010 session, the Codex Alimentarius Commission had postponed the decision to adopt new provisions for one of the Southampton colours, Ponceau 4R in soybean-based beverages due to safety concerns. Until new elements demonstrated the absence of adverse effects of Southampton colorants, the European Union's position would remain unchanged.