Agenda Item 5(b) JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE ON FOOD ADDITIVES Forty-second Session Beijing, China, 15-19 March 2010 CX/FA 10/42/6 Add.1 February 2010 (Original Language Only) COMMENTS AND INFORMATION ON SEVERAL FOOD ADDITIVE PROVISIONS OF GSFA (REPLIES TO CL 2009/07-FA PART B, POINTS 6-9) The following comments have been received from the following Codex members and observers: Argentina, Brazil, European Union, India, Indonesia and Malaysia Point 6 Comments/proposals on uses and use levels of: calcium lignosulfonate (40-65) (INS 1522); ethyl lauroyl arginate (INS 243); steviol glicosides (INS 960) and sulfites Argentina wishes to provide data on the use of sulfites for dehydrated culinary preparations like dehydrated potato granules, flavoured or not flavoured, which contain 0.015% sodium metabisulfite (INS 223), i.e. 150 mg/kg of metabisulfite equivalent to 100 mg/kg of SO 2, therefore, the intake of the ready-to-eat product is 14 mg/kg. According to the JECFA Acceptable Daily Intake of 0 0.7 mg/kg of body weight and the legislation limiting this additive to 40 mg/kg for non-alcoholic beverages, given consumption, it is advisable to reduce the value of 70 mg/kg appearing in Codex Stan 192. Steviol glicosides (INS 960) are allowed as sweeteners in Brazil (Resolution RDC 18/2008) at the maximum level of 600 mg/kg, except for chewing gum at the maximum level of 2400 ppm. This legislation establishes that the use of sweeteners is authorized only for low-sugar foods which are destined to: i) weight control; ii) sugar-controlled diets; iii) sugar-restricted diets; and for foods with nutrition claims related to their sugar content. Sulfites are used as preservative in many food categories in Brazil, for example, vegetable pulp and puree (onion, garlic), coconut milk and vinegars at the level of 100-300 ppm (as SO 2 ). Calcium lignosulfonate (40-65) (INS 1522) and ethyl lauroyl arginate (INS 243) are not allowed as food additives in Brazil yet. Ethyl lauroyl arginate
CX/FA 10/42/6 Add.1 2 The EU would like to stress that the European Food Safety Authority (EFSA) has issued an opinion on 17 April 2007 on the use of ethyl lauroyl arginate as food additive 1 where an ADI of 0.5 mg/kg/ bw has been fixed, based on observed effects on white blood cells in different rat strains. The EU acknowledges the fact that this value differs substantially from the ADI that has been assigned for this substance (0-4 mg/kg/bw) by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) during its 69 th meeting in 2008. Sulphites In 2001, a report from the European Commission 2 already pointed out that the consumption of sulphites in the EU could potentially exceed the ADI. However, this conclusion was based on the assumption that the food additives were used at their maximum use levels (and not on their actual residual levels"). The EU is currently performing a refinement of these food additive dietary intake assessments. JECFA has already flagged major contributors in its 69 th meeting (2008): dried fruits, sausages and non alcoholic beverages, wine, fruit juices and soft juices, processed potatoes and nuts, beer. However, JECFA underlined that these main contributors may differ from one country to another. The same contributors have also been identified by the EU. The EU suggests that specific technological justifications (uses/use levels) should be provided by the competent industry sectors manufacturing the food contributors identified by JECFA, with a particular focus on sausages, fruit juices and wine, as they are widely consumed in some countries. With regard to the category water-based flavoured drinks, the EU proposes to lower the maximum limit to 20 mg/kg. With regard to dried fruits, the EU suggests to split the current authorisation as it seems that for some dried fruits, like apples or pears or nuts, the current ML of 1000 mg/kg seems excessive to achieve the desired effect. The EU suggests lowering the ML to 600 mg/kg. With regard to beer, the current maximum limit of 50 mg/kg should be lowered to 20 mg/kg. Some discussions should also be dealt with under the OIV in order to discuss the possibility to lower maximum limits of sulphites in grape wine. Wine can be considered in the EU as a main contributor for the dietary intake of sulphite leading to an exceedance of the ADI. With regard to processed potatoes and based-snack potatoes, some discussions should be opened in order to lower down the maximum limits. INDONESIA steviol glicosides (INS 960) Indonesia agrees to establish the maximum level of steviol glicosides. For now Indonesia has permitted steviol glicosides as natural sweetener in table top forms. sulfites Indonesia would like to submit data on the current use of sulfites in food and beverages available in our national markets, as follows: No Food additives Food Product 1. Potassium sulfite - soda waters 2. Kalium metabisulfite - stuot - alcoholic beverages 3. Natrium sulfite - whisky - canned fish - concentrates for fruit juice 4. Natrium bisulfite - instant rice vermicelli 1 Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to an application on the use of ethyl lauroyl arginate as a food additive Question number EFSA-Q- 2006-035. 2 COM 2001(542 final) on the dietary food additive intake in the European Union.
CX/FA 10/42/6 Add.1 3 No 5. Food additives Natrium metabisulfite Food Product - chilli sauce - jam diet - yeast - biscuit - pudding - beef sausages - tomato ketchup - dried fruit - chilli sauce - porridge - processed meat - carbonated beverages - nata de coco - food for pregnant mother - syrup - candied fruit - fruit juice - ginseng drink - stout MALAYSIA Steviol glycosides (INS 960) With reference to Malaysia s comments on uses and use level of steviol glycosides (INS 960) in food category 14.1.4.3 Concentrates (liquid or solid) for water-based flavoured drinks, Malaysia would like to amend the proposed maximum level from 8000 mg/kg to 600 mg/kg. This level of use is acceptable. POINT 7 Comments on the application of note 161 Subject to national legislation of the importing country aimed, in particular, at consistency with Section 3.2 of the Preamble, in particular, where and when it should be used Although we understand that this refers to the use, that it may be the case that a country establishes a limit below that set by the GSFA because of the exposure of its population, with the aim of achieving appropriate protection of population, it is deemed appropriate to limit the use of non-nutritive sweeteners and colours as set out in Codex Stan 192, and this could be extended to some preservatives. Argentina does not support the inclusion of this paragraph in a Codex international standard, as the SPS and TBT Agreements allow countries to deviate from the international reference standard provided they have scientific evidence supporting this decision. Unfortunately, the inclusion of paragraphs like these is also occurring in several other Codex documents, and clearly the intention is not understood, unless it is justified by the ignorance of WTO Members rights. Brazil considers that note 161 should be applied to the following cases: The use of the additive negatively affects the food genuineness and identity; The note contributes to protect health due to the high exposure to the additive; The note is proposed to specific products from a country or region. Furthermore, Brazil understands that the non-authorization of a certain food additive in a country should not be conclusive to apply note 161. If there is a Codex Standard for the product it is important to check if the technological need of the food additive and/or its functional purposes were prior discussed by the relevant Codex Committee.
CX/FA 10/42/6 Add.1 4 As a general comment, the EU would like to reiterate that in its opinion food additives should be restricted in fresh, unprocessed, or basic foodstuffs on the ground that for such foodstuffs, at least one among the criteria set in the preamble of the GSFA are not fulfilled, namely the safety aspect, misleading of the consumer or technological need. The GSFA is based on criteria of safety, technological need and consumer benefit. All these criteria have the same weight and the CCFA should always paid attention on whether these three criteria have been systematically investigated before setting proposed uses and use levels for food additives into the GSFA. In addition, the EU is of the view that proposed uses and use levels for a food additive should be more systematically accompanied by a dietary intake estimate that should be performed by JECFA. The EU is of the opinion that the note 161 subject to national legislation of the importing country, aimed, in particular, at consistency with Section 3.2 of the Preamble should always be applied on a case by case basis and only where proposals have the potential of not being in line with the criteria set under section 3.2 of the preamble of the GSFA. The EU acknowledges that the application of the criteria set in section 3.2 of the preamble of the GSFA for some specific food additive provisions might sometimes be difficult to apply, bearing in mind that various factors relating to the technological need (e.g. different climate conditions between different parts of the world, different consumers perception to food additives (in particular with regard to food colours), different food cultures, food technology or food hygienic standards ) and different consumption habits (related to the intake estimate) are taken on board by Codex countries, affected to their own ranking of priority, which may end up with divergence of views regarding food additive proposals. The EU acknowledges that the note 161 is not an ideal tool and the EU recognises that an alternative should be found in the future. The EU suggests that the general principles of the current preamble to the GSFA should be amended in order to take into account, in addition to the criteria already mentioned in the section 3.2 of the preamble, the particularity that technological needs and/or consumer expectations and consumption habits may differ among Codex countries, and as a consequence a country could set in its legislation lower limits or limited uses. INDIA As per the General Principles of Codex Alimentarius Commission (reference 18th Edition of procedural manual) Codex standards and related texts are not a substitute for, or alternative to national legislation. Every country s laws and administrative procedures contain provisions with which it is essential to comply. Also, as per Article 3 of SPS Agreement states that Members may introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines or recommendations, if there is a scientific justification. We are of the opinion that note 161 should be used sparingly and as an option, only in such cases when there are differences in the views of the members with respect to the suitability of specific food additive(s), of a technologically approved food additive class, in a particular food. However, in cases where the proposed use of specific food additive(s) is accepted and the differences in views only pertain to the level of usage, the highest level that would not result in the ADI being exceeded, should be allowed for use, without resorting to the use of the note 161. POINT 8 Information on the technological justification for the use of fast green FCF (INS 143) in food category 06.4.2 Dried pastas and noodles and like products Argentina s legislation does not permit the use in this category.
CX/FA 10/42/6 Add.1 5 Only natural colours are allowed in Brazil and Mercosur for this food category. However, they are not authorized for pastas that contain vegetables (for example, carrots, beets). This restriction is important to reduce the exposure to artificial colours, mainly of children, since they can be high consumers of this product. Besides, we understand that the use of colours in pastas made with vegetables could mislead consumers and change the identity of the product. The EU does not support the use of Fast green FCF in dried pastas as the consumer could be misled. However, the EU takes note that the Stan 249-2006 for instant noodles allows the use of Fast green FCF. The EU requests clarification on the technological need for such a use. Point 9 Information on the technological justification for use of erythrosine (INS 127) in food categories 08.2 Processed meat, poultry, and game products in whole pieces and cuts and 08.3 Processed comminuted meat, poultry, and game products In Argentina the use of erythrosine is limited to some food categories and is not permitted for any kind of meat products as the ADI is 0-0.1 mg/kg of body weight. Argentina only permits the use of natural colours in meat products. Erythrosine is not allowed for meat products in Brazil. Erythrosine was allocated a very low ADI of 0.5 mg/kg bw/d both by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Scientific Committee on Food (SCF), respectively in 1990 and 1987. Due to the high potential risk of exceeding the very low ADI when authorising the proposed uses, the EU suggests restricting the use of erythrosine as much as possible, notably in foodstuffs that are widely consumed. The potential risk of exceeding the ADI has been noted by JECFA. A refined exposure assessment should be performed by JECFA. The EU is opposed to the use of erythrosine in meat products and processed meat having concern on intake, questioning the technological need and having concern about misleading the consumer. Finally, the EU requests some clarification about the technological justification to authorise such food additives in processed meat and meat products. Some justifications are also needed to ensure that the consumers are not misled. INDONESIA Indonesia agrees to discontinue the use of erythrosine in food categories 08.2 Processed meat, poultry, and game products in whole pieces and cuts and 08.3 Processed comminuted meat, poultry, and game products. Justification : Erythrosine has low ADI (0-0.1 mg/kg bw) and the addition of it may mask the bad quality of the food products and may mislead consumers.