E SUB-COMMITTEE ON CARRIAGE OF CARGOES AND CONTAINERS 4th session Agenda item 6 CCC 4/6/14 7 July 2017 Original: ENGLISH AMENDMENTS TO THE IMDG CODE AND SUPPLEMENTS Proposed amendment to the shipping provisions for FISHMEAL (FISHSCRAP), STABILIZED (UN 2216) Submitted by Peru SUMMARY Executive summary: This document contains a proposal to modify the draft amendments to the shipping provisions in the IMDG Code for the transport of fishmeal Strategic direction: 5.2 High-level action: 5.2.3 Output: 5.2.3.4 Action to be taken: Paragraph 15 Related documents: CCC 4/6, annex 2 and CCC 4/INF.12 Introduction 1 This document comments on the outcome of E&T 27 regarding the draft amendments (39-18) to the IMDG Code (part 1) (CCC 4/6, annex 2), specifically the draft amendments to SP 308 and SP 945 relating to FISHMEAL (FISHSCRAP), STABILIZED (UN 2216). Associated self-heating test results have been submitted as document CCC 4/INF.12. 2 Fishmeal has been stabilized by the addition of the antioxidant ethoxyquin (EQ) for many years. The current addition and residue levels of ethoxyquin listed in the IMDG Code were decided on more than 40 years ago and are at levels well in excess of those that will achieve stabilization. Unnecessarily high levels of ethoxyquin in fishmeal are undesirable and may lead to high residue levels in the animal which has been fed with feed which incorporates the treated fishmeal as a feed ingredient. Increased negative publicity in the European Union has drawn attention to the use of ethoxyquin and its presence in feed and food. A 12-month fishmeal stability trial undertaken by IFFO The Marine Ingredients Organization (IFFO) compared the stability of fishmeal treated with lower inclusion rates of ethoxyquin as well as other antioxidants, butylated hydroxytoluene (BHT) and a natural tocopherol/rosemary extract
Page 2 blend. It is important to consider alternative antioxidant options, apart from ethoxyquin, in case ethoxyquin is not reauthorized in the EU and also in order to provide greater choice in the market. In many cases, requests for the discontinuation of the use, lower residual levels, or replacement of synthetic antioxidants with natural antioxidants have been received by fishmeal producers. Background 3 The European Food Safety Authority (EFSA) published their Opinion on ethoxyquin in November 2015 as part of an animal feed additive reauthorization process. That Opinion states that safety regarding the use of ethoxyquin remains inconclusive and identified knowledge gaps where data is required to make an overall assessment of the safety of ethoxyquin 1. The European Commission has, based on the EFSA Opinion, approved and subsequently published a regulation on the suspension of ethoxyquin which provides certain derogations for its use in specific feed materials and feed additives. The Commission Regulation (EU) 2017/962 suspending the authorization of ethoxyquin as a feed additive was published in the Official Journal of the European Union (OJEU) on 8 June 2017 and came into force on 28 June 2017 2. According to the Regulation, fishmeal produced with ethoxyquin may be placed on the market until 31 December 2019. A new EFSA Opinion, which will be based on the additional safety data, will result in either the authorization of its use or ban the use of ethoxyquin permanently. 4 Lower dosage levels of ethoxyquin in all volumes of fishmeal are necessary to manage levels throughout the food supply chain and alleviate concerns around its safety. The future of ethoxyquin is uncertain and additional options for the transport of fishmeal are necessary. 5 The IFFO 12-month fishmeal stability trial has provided proof for the following amendment to be accepted into the Model Regulations by the UN Sub-Committee of Experts on the Transport of Dangerous Goods in November 2016: "SP 308 Stabilization of fishmeal shall be achieved to prevent spontaneous combustion by effective application of ethoxyquin, BHT (butylated hydroxytoluene) or tocopherols (also used in a blend with rosemary extract) at the time of production. The said application shall occur within 12 months prior to shipment. Fish scrap or fish meal shall contain at least 50 ppm (mg/kg) of ethoxyquin, 100 ppm (mg/kg) of BHT or 250 ppm (mg/kg) of tocopherol based antioxidant at the time of consignment." 6 The amendment was put forward to E&T 27 (8 to 12 May 2017) to be incorporated into the IMDG Code and the following amended text has been provisionally accepted into SP 308 and SP 945 (CCC 4/6, annex 2): SP 308 Amend to read as follows: "For packages containing not more than 3,000 kg, stabilization of fishmeal shall be achieved to prevent spontaneous combustion by effective application of ethoxyquin, BHT (butylated hydroxytoluene) or tocopherols (also used in a blend with rosemary extract) at the time of production. The said application shall occur within 12 months prior to shipment. Fish scrap or fish meal shall contain at least 50 ppm (mg/kg) of ethoxyquin, 100 ppm (mg/kg) of BHT or 250 ppm (mg/kg) of tocopherol based antioxidant at the time of shipment." 1 2 http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4272/epdf http://eur-lex.europa.eu/legal-content/en/txt/?qid=1497947119848&uri=celex:32017r0962
Page 3 SP 945 Amend this special provision to read as follows: "[For portable tanks and bulk containers containing more than 3000 kg, stabilization of fish scrap or fishmeal shall be achieved to prevent spontaneous combustion by effective application of between 400 and 1,000 ppm (mg/kg) ethoxyquin, or between 2,000 and 4,000 ppm (mg/kg) BHT (butylated hydroxytoluene) at the time of production. The said application shall occur no longer than twelve months prior to shipment. At the time of shipment, the fish scrap or fishmeal shall contain at least 100 ppm (mg/kg) ethoxyquin or BHT based antioxidant.]" 7 Following discussion, E&T 27 agreed on the new provisions for stabilization by tocopherol but restricted the application to non-bulk packages, i.e. to packages not exceeding 3 m³ capacity as well as the lower residual ethoxyquin levels once again only for packages < 3,000 kg. The technical basis for this threshold is unclear, and it could be argued that as the volume of the packed fishmeal increases so the surface area exposure to the air (per unit volume) theoretically decreases, effectively reducing the risk of oxidation, not increasing it. Discussion 8 The weight limit of 3,000 kg written into SP 308 and SP 945 in the draft amendments (39-18) to the IMDG Code, as prepared by E&T 27, poses a serious concern for the fishmeal producing industry since a significant volume of fishmeal is shipped in bulk in containers as well as in bulk in the ship's hold. According to a recent survey of our members to ascertain the format that fishmeal is shipped in, more than 35% of fishmeal is shipped in bulk (in container or ship's hold). 9 During the IFFO trials, the fishmeal was stored for 12 months in 50 kg and 1 ton bags and the following self-heating data sets have been included in document CCC 4/INF.12: After 6 months' storage, the lowest dosage level of all the treatments were tested in the 1 ton bags. That is: 6 months - BHT solution 2000 ppm (amount to 440 ppm BHT) 1 ton bag; - Ethoxyquin 300 ppm 1 ton bag; and - Tocopherol solution 2000 ppm (amount to 390 ppm tocopherol) 1 ton bag. After 12 months' storage, all the treatments and storage volumes were tested for self-heating: 12 months - BHT solution 2000 ppm (amount to 440 ppm BHT) 1 ton bag; - BHT solution 2000 ppm (amount to 440 ppm BHT) 50 kg bag; - BHT solution 4000 ppm (amount to 860 ppm BHT) 1 ton bag; - BHT solution 4000 ppm (amount to 860 ppm BHT) 50 kg bag; - Ethoxyquin 300 ppm 1 ton bag; - Ethoxyquin 300 ppm 50 kg bag; - Ethoxyquin 50 ppm 1 ton bag; - Ethoxyquin 30 ppm 50 kg bag; - Tocopherol solution 2000 ppm (amount to 390 ppm tocopherol) 1 ton bag; - Tocopherol solution (amount to 390 ppm tocopherol) 2000 ppm 50 kg bag; - Tocopherol solution (amount to 630 ppm tocopherol) 4000 ppm 1 ton bag; and - Tocopherol solution (amount to 630 ppm tocopherol) 4000 ppm 50 kg bag
Page 4 10 The highlighted samples are the relevant treatments for the requested amendment (lower residual ethoxyquin levels and the inclusion of tocopherols). After 6 months' storage, all the samples that contained the lowest dosage levels passed the self-heating test (therefore, it can be safely assumed that the higher dosage levels would also have passed) and the temperature did not increase by more than 10 C during the test for any of the samples. All the samples can, therefore, be considered not to be Material Hazardous in Bulk (MHB). 11 After twelve months' storage, all the samples passed the self-heating test but for some the temperature increased by > 10 C (when stored at 140 C) and unfortunately, the 100 C test was not performed as we had not realised that it may be necessary. The antioxidant levels had decreased considerably after 12 months storage and therefore slightly higher temperatures being reached during the test are understandable. Fishmeal is generally shipped within a one to five-month period after production. The maximum temperature reached during the self-heating test for the relevant treatments after twelve months' storage was 157.8 C (a temperature increase of only 17.8 C) for the Tocopherol 630 ppm 1 ton treatment and 154 C for the Ethoxyquin 300 ppm 1 ton treatment, which is far away from the 60 C increase (maximum sample temp of 200 C) that is the fail criterion. These temperature increases are low enough to demonstrate that the proposed amendments are safe for fishmeal >3,000 kg and there is, therefore, no justification to apply the restriction to 3,000 kg. To demonstrate that these temperatures are safe after twelve months for the requested dosage levels, it can be seen that the BHT treatments, at levels proven to be safe after more than 30 years of use, also reached a maximum temperature of 161.2 C. There is, therefore, clear evidence that the criteria of class 4.2 are not met in any of these samples. As consequence, the amended conditions for stabilization of fishmeal with reduced ethoxyquin and tocopherol as an alternative should be accepted also for a bulk container. 12 In addition, the BHT dosage format needs to be clarified. BHT is available in varying concentrations of dosage solutions (of around 20-30% BHT) for use in the treatment of fishmeal (BHT cannot be applied in powder form). The concentration of BHT in solutions may therefore vary and the initial BHT content (the active component) should be stipulated, if necessary, rather than the dosage solution. 13 Furthermore, the E&T Group agreed to increase the minimum BHT dosage to 2,000 ppm (from 1,000 ppm) since that was the dosages used in the stability trial. The use of the1,000 ppm level has historically been proven safe from the time that it was written into the IMDG Code and there is no need to change it because of alternative levels used in the stability trial. The BHT levels used in the trial were intended as comparative values against tocopherols and ethoxyquin and not as new proposed dosage levels. The industry is aiming to reduce the dosage levels of synthetic antioxidants, not to increase them. The actual active ingredient BHT dosage levels needs to be (so that it is in line with the original 1,000 to 4,000 ppm of a 20% BHT solution) 200 to 800 ppm BHT. The levels used in the stability trial were 440 to 860 ppm. Similarly, tocopherols are also applied in formulations containing varying concentration of tocopherols. In fact, SP 945 is not used in the industry, so this creates confusion. The residual levels specified in SP 308 determine the dosage levels and SP 945 is, therefore, superfluous. The dosage levels in fishmeal are not controlled. In addition, the dosage levels result in uncertainty of the actual antioxidant dosage due to varying antioxidant formulations with different concentrations.
Page 5 Proposal 14 Amend SP 308 and SP 945 as proposed below:.1 delete the restriction of 3,000 kg in SP 308 "For packages containing not more than 3,000 kg,.."; and.2 delete SP 945. Action requested of the Sub-Committee 15 The Sub-Committee is invited to consider the comments and proposals provided in this document and take action as appropriate.