European Union GMO Regulations
U.S. food and beverage manufacturers can experience costly and delayed customs clearance and unsuccessful export attempts to the European Union (EU) if they are unfamiliar with genetically modified organism (GMO) regulations in the EU.
The EU established Regulation (EC) 1829/2003 on genetically modified food and feed to ensure that the development of modern biotechnology, specifically GMOs, takes place safely. This Regulation provides the general framework for regulating genetically modified (GM) food and feed in the EU.
All GM food and feed placed on the EU market have to be authorized by the European Commission. Authorization of GM food and feed is based on an independent risk assessment by the European Food Safety Authority (EFSA). U.S. food and beverage manufacturers can apply for authorization to place a GM product on the EU market if the product has not already been authorized. The authorization process can take several months. Authorizations will be granted for a period of 10 years and are renewable for 10-year periods.
U.S. food and beverage manufacturers exporting authorized GM products to the EU must reference the presence of GMOs on their product labels. However, this requirement does not apply to food which contain, consists of, or is produced from GMOs in a proportion no higher than 0.9% of the food ingredients considered individually and if this presence is adventitious or technically unavoidable. This labeling allows the consumers to make an informed choice.
Products made of or containing GMOs are subject to traceability requirements. U.S. food and beverage manufacturers and other operators must provide the following in writing to whom they supply the product: an indication that the product or certain ingredients contains, consists of, or is obtained from GMOs; and information on the unique identifier(s) for these GMOs.
An authorized GMO in the EU may not necessarily be authorized in a Member State. Member States may provisionally restrict or prohibit the use and/or sale of a GM product on its territory through a safeguard clause (Art. 23 Dir. 2001/18/EC). Austria, France, Greece, Hungary, Germany, and Luxembourg currently apply safeguard clauses.
U.S. food and beverage manufacturers can manage the quick and successful export of their GM products by doing the following before exporting: ensure all GMOs in the product are authorized in the EU, create product labels that have the required GMO references, have GMO statements and information on the GMO unique identifiers, and check individual Member State regulations.
Source: European Commission