Guidelines on preventing Ethylene Oxide contamination in spices exported to EU

Ethylene oxide (ETO) is a flammable, colourless gas at temperatures above 51.3 F (10.7 C). When used directly in the gaseous form or in nonexplosive gaseous mixtures with nitrogen or carbon dioxide, ETO serves as a disinfectant, fumigant, sterilizing agent, and insecticide. The major use of ETO is the sterilization of medical equipment. ETO is also used to reduce microbial contamination in a post-harvest stage in plant products including spices, 2-Chloroethanol or ECH is the degraded product of ETO.

ETO has also been reported to be produced from natural sources. In certain plants, ethylene (a natural plant growth regulator) is degraded to ethylene oxide. It is also a product of ethylene catabolism in certain microorganisms. ETO is also generated from water-logged soil, manure and sewage sludge. Quantitative estimates of production from these natural sources are not studied much. But emissions are expected to be negligible.

EU Regulation on ETO:

The current EU legislation regulating residues of ethylene oxide (sum of ethylene oxide and 2-chloroethanol expressed as ethylene oxide) is Commission Regulation (EU) 2015/868, which sets the MRL (Maximum Residue Level) for the sum of ETO and ECH in herbs and spices.

The use of ETO for the sterilization of foodstuffs within the EU as well as the import of foodstuffs containing residues of ETO and ECH above the MRLs into the EU is illegal.

Applications of biocidal products containing ethylene oxide are allowed for disinfection in the EU but without food contact.

Preventive measures for ETO contamination:

• Exporters of Spices to the EU shall not use ETO as a sterilizing agent to reduce microbial contamination in spices consignments intended for export to the EU.
• Exporters are advised to check and test their raw materials, processing aids and finished goods for ETO contamination.
• On instances of ETO detection, exporters shall not export the products to EU.
• Root cause analysis for its occurrence and preventive measures to be followed should be recorded for future compliance.
• Frequency of raw material check should be increased for such supply and suppliers.
• Exporters shall include ETO as a hazard in their hazard analysis critical control points (HACCP).
• Exporters shall include voluntary testing of ETO during raw material procurement and on a final product intended to be exported to EU as a monitoring measure.
• Exporters shall ensure that transporters, storage houses, packaging material suppliers, cold storage etc. shall not use ETO during any processes.
• ETO treated products intended for destinations other than EU shall be separately processed, stored & transported at all times to prevent cross-contamination.
• Exporters of organic spices to EU shall follow the guidelines/ advisories on prevention of ETO contamination in organic products issued by APEDA / Organic Certification Bodies under NPOP.
• In case the exporters have their own ETO sterilization unit, areas where ETO is used should be demarcated and adequate measures should be taken to prevent the cross-contamination with spices intended for export to the EU.
• Food Safety/ HACCP Plan shall be established and implemented to control the cross-contamination of spices and spice products.
• Spice unit shall monitor the ETO /its residue in spices and spices products and keep records.
• Awareness training on not to use ETO sterilization for EU exports shall be imparted to all the stakeholders including raw material suppliers/Traders/processors.

Alternate methods of sterilization:

Exporters of spices to the EU are encouraged to use alternate methods of sterilization as suitable.

1. Steam Sterilization
2. Irradiation (not applicable to organic products under NPOP)
3. any other suitable methods

Guidance on microbial load reduction:

Exporters of spices are advised to adhere to the following guidelines in processing of spices to reduce/eliminate microbial contamination in spices.

1. Codex General Principles of Food Hygiene
2. Code of Hygienic Practices for Low Moisture Foods
3. Requirements of Schedule IV of Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations 2011

Incoming material requirements:

• Spices, herbs and their source plants shall not be accepted by the establishment if they are known to certain contaminants which will not be reduced to acceptable levels normal processing procedures, sorting or preparation.
• Precautions shall be taken to minimize the chances for cross contamination of the establishment and other products from incoming materials that may be contaminated.
• Plants & plant parts, used as spices and herbs, if suspected of being contaminated with any fifty material, shall be rejected.
• Special precautions shall be taken to reject spices and herbs showing signs of pest damage/infestation or mould growth. So as to eliminate the potential hazard of mycotoxins such as aflatoxins.
• Raw materials shall be inspected (for foreign matter, odour and appearance. Visible mould contamination etc.) cleaned if needed and sorted prior to processing. Laboratory tests, e.g. for moulds or pathogens such as salmonella, shall be conducted when necessary.
• Because of the diversity of the production practices for spices and herbs, it is important to be understand the controls in place for production of the incoming material. Spices and herbs shall be obtained from approved suppliers. An approved suppliers. An approved supplier is one that can provide a high degree of assurance that appropriate controls have been implemented to minimize the possibility of chemical. Physical and microbiological contamination.
• If the control measures used to produce the spices and herbs are not known, verification activities such as inspection and testing shall be increased consideration shall be given to a program for testing spices and herbs.

Measures to prevent cross contamination:

• Effective measures shall be taken to prevent cross-contamination of spices and herbs by direct or indirect contact with potentially contaminated material at all stages of the processing. Raw products that may prevent a potential hazard shall be processed in separate rooms, or in areas physically separate from those where end-products are being prepared/stored.
• Spices and herbs that have undergone a microbial reduction treatment shall be processed and stored separately from untreated spices and herbs.
• Customs bonded warehouses/ external storage areas shall also comply with the requirement of having separate storage spaces for ETO treated and non-treated materials to avoid cross-contamination. As far as possible, it shall be ensured that products intended for expert to the EU shall be stored separately, without proximity to export items intended to non-EU countries.
• The equipment which has been used to handle treated products shall be adequately cleaned and disinfected after use. Care shall be taken to avoid use of equipment to handle both treated and untreated products, without adequate cleaning and disinfection.

Packaging:

• Non-porous bags/containers shall be used to protect the spices and herbs from contamination, occurrence of moisture and infestation of insects and rodents. In particular, the re-absorption of ambient moisture shall be prevented. Contamination shall be prevented by the use of liners where appropriate.
• It is recommended that new bags or containers be used for food contact packaging. All bags/containers shall be in good condition and particular attention shall be paid to avoid loose bag fibres that can become potential contaminants.
• Spices and herbs e.g. dried chilli peppers shall not be sprayed with water to prevent breakage during packing. This may result in growth of moulds and microbial pathogens.
• Finished products may be packed in gas tight containers preferably under inert gases like nitrogen or under vacuum in order to retard possible microbial growth.

Transportation:

• While moving the commodity into or out of the warehouse, adequate care shall be taken to ensure protection from any of the external adverse environmental factors like rain, high temperature, humidity etc. During transportation, attention shall be given to avoid exposure to water/moisture and to ensure that pests or debris do not penetrate into the commodity.
• Regular checks shall be made to ensure that the transporting vehicle is covered, that there are no rips in the covers and no leaks on the undersides of vehicle which could allow water from the road to get into the vehicle.
• Bags shall preferably be placed on pallets to avoid contact with the floor. The pallets and frames used for transportation shall be hygienic and dry.
• Spices absorb moisture quickly if the bags get wet, resulting in considerable increases in moisture content. For products that require a long period for transportation, temperature and humidity shall be monitored where appropriate.
• Fully ventilated containers are preferable for transporting spices in bags, especially if shipped from a high humidity region. Desiccant boxes filled with calcium chloride can absorb around 100% of their own weight in moisture and may be used for added protection.
• Care shall be taken not to be damage the dry-bags packed with spices and any spillages shall be cleaned immediately.
• Ample space shall be maintained between bags and the roof of the vehicle. Use of the saddle slow method, which minimizes side contact and maximizes airflow between the bags, is recommended.
• While transporting spices and herbs in bulk (E.g. by ship or rail), care shall be taken to ensure adequate ventilation, so as to prevent moisture condensation, resulting from respiration, movement of vehicle from a warmer to cooler region or from day to night etc.
• Prior to bulk transport, the products must be dried to safe moisture level to prevent the growth of mould and pathogens.

Sample handling and testing:

• Adequate care shall be taken while handling samples for testing so as to eliminate the possibility off cross contamination from gloves, sampling equipment etc.
• Appropriate testing methods shall be employed for testing of ETO in spices. E.g. Based on EURL-SRM: Analysis of Ethylene Oxide and its Metabolite 2-Chloroethanol using GC-MS.

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