Leg. Dev.: Novel Foods and Food Ingredients

3 Colum. J. Eur. L. 317 (1997)

Christopher Wyeth Kirkham.

On January 27, 1997, the European Parliament and the Council adopted Regulation No. 258197 of the European Parliament and the Council concerning novel foods and novel food ingredients. The Regulation, which augments a 1979 directive on labeling, was implemented to address the marketing and labeling of novel food products, such as genetically engineered foods or ingredients. The labeling requirements generally apply to food stuffs or ingredients that have not previously been placed on the Community market for human consumption, and which fall into at least one of the following categories: (1) containing or consisting of genetically modified organisms(GMOs) within the meaning of Directive 90/220/EEC3; (2) produced from (even if not containing) GMOs; (3) having a new or modified genetic structure; (4) consisting of or isolated from microorganisms; (5) consisting of or isolated from plants or animals; and (6) created from a production process not currently used, when the process causes a significant change in the structure of the foods or the food ingredients (Article 1). Furthermore, foods falling within the Regulation’s scope must not mislead or present a danger to consumers. The Regulation’s requirements apply without prejudice to other food regulations with which any such food stuffs must comply (Article 3).

The Regulation was proposed in 1992 by the Commission4 in response to “a new range of raw materials, processes and technologies, including but not only modem biotechnology and genetic modification techniques, [that] have emerged. “The Commission believed it necessary “to create a Community procedure for the placing on the market of ‘novel foods’ resulting from these innovations and to provide for a safety assessment and for precise labeling provisions.’” The Commission has since outlined more specific objectives of the Regulation. The consumer-oriented objectives of the Regulation are to increase transparency, improve consumer confidence in food stuffs and provide for the public health. For the internal market, the principle goals of the Regulation are to create consistency within the market, to remove hindrances to the free flow of food stuffs and to eliminate unfair competition that has arisen from the lack of regulation in this area.

Recognizing certain limitations of the Regulation, the Commission issued a press release stating that should experience expose gaps within the legislation, further measures will be taken to protect public health. This release responds to two general areas of controversy surrounding the legislation that delayed its implementation. First, certain Members of the European Parliament (MEPs)\ and consumer groups opposed the legislation because it does not guarantee enough consumer protection. These opponents believe that the Regulation’s licensing rules are too loose, since certain novel foods items can be marketed after mere notification of the Commission, while other novel food stuffs do not have to be labeled at all. Second, the Regulation preempts any Member State initiative in this area, and these groups oppose the fact that Member States may not implement stricter labeling measures than those established under the Community Regulation.”

Three particular limitations of the measure triggered the objections of MEPs. First, the Regulation requires labeling only when the alteration is outside the range of natural variations and only when the modifications effect the finished food product, as opposed to the raw material (Article 8).12 Second, Article 3 of the Regulation sets out the foods and food ingredients not covered by the measure, including food additives and food flavorings. Despite a suggestion from the Parliament, the Council decided not to expand the scope of the Regulation to include food additives, as Community regulations already exist in that area.” Third, foods need not be assessed if, based on scientific evidence, they are “substantially equivalent” to existing foods. In such cases, the manufacturer is required only to notify and provide the Commission with information about the products before placing the food on the market. The Commission must then give copies of the notification to Member States and publish a summary in the “C” series of the Official Journal (Article 5).

To overcome some of these concerns, the Regulation provides certain specific labeling requirements as additional safety procedures. These requirements are aimed at ensuring that the consumer is informed of any composition, nutritional value, or intended use of the food that differs from similar natural foods (Article 8). If the food contains a GMO, the applicant must supply to the Commission additional information: a written consent of the release of the organism, the complete technical dossier, and an environmental risk assessment (Article 9). The Regulation also requires that the Commission consult the Scientific Committee for Food on possible health effects (Article 11). Pursuant to this provision, a Member State that believes there is a health risk associated with the food has the right to suspend trade in or use of the food or food ingredient. The Member State must then inform the Commission of its grounds for action (Article 12). These provisions allow Member States some additional control over the process to further alleviate some of the voiced concerns.

The initial approval and assessment procedure is purposefully simple, having been adopted to speed up the approval process and provide one uniform decision. The Economic and Social Committee advised such expediency for fear that lengthy procedures could result in approval taking up to three years. This need for expediency also induced the Commission to set implementation of the Regulation within 90 days after publication in the Official Journal (rather than within twelve months, as originally planned).

The procedure for application and assessment requires that the applicant submit a request to authorities of the Member State in which the product will be introduced. The applicant must forward a copy of this request to the Commission (Article 4). The request must provide information, including studies, to prove that the food complies with the Regulation. The request must also contain a proposal for the type of labeling that will be used. The Member State is responsible for naming an assessment body to prepare an initial assessment report within three months of the application. This report is provided to the Commission, which will assess the information itself and forward its determinations to Member States. The Member States are then allowed a 60-day period to make objections (Article 6). Also, to give Member States more of a voice in the process, Article 13 requires that the Commission be aided in all decisions by the Standing Committee for Foodstuffs. The Commission shall submit a draft of the proposed measures to this Committee, which will deliver its opinion in accordance with the Community voting procedures in Article 148 of the EC Treaty. In the event that an objection is made or further assessment needed, the Commission may make an authorization decision (Article 13), and, if necessary, set conditions for the use of the food item, designation of the food, and specific labeling requirements (Article 7).

Within five years of implementation, the Commission shall provide the Council with a report on the Regulation. The Commission is also charged with monitoring the impact of the Regulation on consumer health, protection and information as well as the functioning of the Regulation in the internal market (Article 14). These additions represent further safeguards against any gaps within the measures provided. The Regulation will enter into force on May 15, 1997 (Article 15).