FVO report – GM Papaya export from Thailand

This report is of extreme interest because it refers to one of the emerging problems stressed by RASFF notifications and statistics during the last months.

The report describes the outcome of a Food and Veterinary Office (FVO) audit in Thailand, carried out between 29 January to 07 February 2014. Genetically modified (GM) papaya is not authorised in the European Union (EU). The objective of the audit was to assess the system of controls to ensure that GM papaya and GM papaya products are not exported to the EU.

The audit was carried out due to RASFF notifications of genetically modified organism (GMO) in papaya and papaya products from Thailand issued in 2012 and 2013. Although GM papaya has never been authorised for cultivation in Thailand, the CA detected a
significant presence of GM papaya. The origin of the GM papaya is not known. There is an incentive for farmers to use GM papaya as non-GM plants are susceptible to the serious disease PRSV. The farmers met had been using farm saved papaya seed for a number of years and the original seed was sourced before official GMO controls started.

In response to the RASFF notifications issued by the EU from 2012, the CA has put in place a system to ensure that GM papaya is not exported to the EU. The system is based on obligatory export certification, and papaya intended for export to the EU must be sampled and analysed for GMO presence. However, DOA does not verify whether sampling for export certification is representative. The CA requires GMP certification of packing facilities and performs official annual surveillance schemes. Certification of papaya growers to the GAP scheme is encouraged and includes systematic testing for GMOs. However, GAP certification is currently not compulsory and a number of growers of papaya for export to the EU are not certified.

Some shortcomings were identified in the GMO laboratories such as sensitivity and quality control procedures. Official controls are supported by additional private controls.

While the control measures are capable of ensuring that papaya exported to the EU is not GM, the system put in place requires more time to be completed. At the time of the audit it was too early to conclude on its effectiveness.

 

Frutarom Launches New Phytopharmaceutical Ingredients Line

Frutarom Health BU, Switzerland, announces the launch of EFLA®pharm, a flagship proprietary product line comprised of both phytopharmaceutical ingredients and pharma flavors. The new product line for the pharmaceutical industry expands the established EFLA® brand, offering increased value to the pharmaceutical industry plus expertise in building a supply chain for sustainable, natural Active Pharmaceutical Ingredients that meet pharmaceutical manufacturers‘ needs. The EFLApharm family of products are scientifically supported, natural, pharmaceutical-grade herbal extracts. All are produced according to strict GMP guidelines.

Examples of herbals used in traditional medicine products under the EFLApharm brand include: Echinacea purpurea L.(purple coneflower), Hedera helix L. (common ivy), and Thymus vulgaris L. (thyme), all of which are key ingredients in the growing field of cough and cold therapeutics.

With the tremendous expansion in the use of traditional medicine worldwide, safety and efficacy — as well as quality control—of herbal medicines and traditional procedure-based therapies are major concerns for health authorities and the public.

Regulatory authorities protect public health while securing free movement of herbal medicinal products within a community, thus the process for licensing and information on herbal substances is being increasingly harmonized. EFLApharm products fall into the Traditional Herbal Medicinal Products (THMP) regulatory framework, and are suitable for global, pharmaceutical-quality submission, including the Drug Master File.

“Quality continues to be a major theme across the nutritional and pharmaceutical ingredients marketplace,” says Hadar Sutovsky, Global Manager of the Pharma & OTC segment at the Frutarom Health Business Unit. “Companies throughout the supply chain are taking a closer look at the quality of their ingredients and trying to determine better ways to deliver finished products of the highest quality. With EFLApharm, we can simplify access to the market for pharmaceutical companies striving to launch safe and effective herbal medicines.”

Active pharmaceutical ingredients sometimes taste bitter and/or irritate the mouth and throat, and thus are unpleasant not only to children but also to many adults. Flavorants are commonly used in pharmaceutical oral solutions and oral suspensions to mask bitterness and make the formulation more palatable. EFLApharm products offer GMP-quality fruitflavors with long-lasting taste profiles and masking properties. The ingredients are perfectly suited for oral care products, nutritional supplements, cough syrups and other pharmaceutical dosage forms.