Under the new proposed rules, harmonized Community rules would be laid down for the evaluation, approval and control of enzymes used in food. At the same time, the EU Executive proposes to review the current rules on food additives and flavorings and to introduce a simplified common Community approval procedure for food additives, flavorings and enzymes.
Enzymes
The new proposed legislation regulates enzymes for the first time at the EU level. Currently, only enzymes used as food additives are covered by the law on food additives and only two enzymes (lysozyme and invertase) are authorized under this legislation.
The proposal also includes labeling requirements for enzymes which have a technological function in the final food. They will be labeled as ingredients with their function (e.g. stabilizer) and name while enzymes used as processing aids are exempted from labeling.
In addition, the new rules require that enzymes that consist of, contain or are produced from genetically modified organisms (GMOs) should be evaluated under the Regulation on GM food and feed prior to authorization of the enzyme itself under this regulation.
The impact of labeling and the Community authorization system will be mitigated by the introduction of a transitional period which allows new enzymes to be marketed under current national laws until the Community positive list is established. A period of 24 months would then be provided for the submission of applications for existing enzymes.
Additives
The new proposed legislation further harmonizes the legislation on additives and clarifies the rules by bringing together all additive legislation on sweeteners, colors and others into one single instrument.
The proposed Regulation widens the scope of additive legislation to include additives used in additives and enzymes. It also removes from its scope enzymes used for additive functions as these are regulated by a separated proposal for a Regulation on food enzymes as described above. All applications for the approvals of new food additives would be based on a safety evaluation carried out by EFSA (previously undertaken by the Scientific Committee on Food).
In addition, the proposal introduces a requirement to ensure that all additives which consist, contain or are produced from GMOs should be authorized under the Regulation on GM food and feed (Regulation No 1829/2003) prior to being permitted under additives legislation.
Finally, the labeling requirements of food additives sold to the manufacturer or directly to the consumer will be updated in particular to inform where the additive consists, contains or is produced from genetically modified organisms.
Flavorings
The new proposed legislation on flavorings replaces the framework Directive on flavorings laid down in Directive 88/388/EEC which needed to be updated in light of the technological and scientific developments. The Commission Directive 91/71/EEC completing the 1988 framework legislation on flavorings will also be repealed and replaced by the present proposed rules.
The new legislation brings clarification to the definition of flavorings, and introduces stricter conditions for the use of the term 'natural' when describing flavorings and brings simplification by removing the distinction between natural identical and artificial flavoring substances.
Finally, the new draft Regulation further harmonizes the legislation on flavorings by setting clearer rules on maximum levels for undesirable substances, in line with EFSA opinions.
Introduction of a common authorization procedure
The key aspect of the legislation is the introduction of a single common procedure for the approval of food additives, flavorings and enzymes. This approval procedure includes a safety evaluation by EFSA.
All four proposed Regulations will need the approval of the European Parliament and the Council of Ministers before becoming EU law, a process that is likely to take at least 18 months. Once the new rules are adopted, they will apply to all EU Member States.
The Implications for Industry
While many EU businesses and industry groups have lauded the initiative as a needed change, in that it provides a measure of predictability, the response here in the United States has been markedly more cautious. There is general concern that the measures, which the EC has indicated are designed to streamline the approval of additives, colors, flavorings and enzymes, could result in a longer procedure, with some presently approved ingredients potentially restricted in the future.
Underlying all of these discussions is a concern that the revised process will be predicated on the precautionary principle. The precautionary principle, which is a fundamental element of the EU's regulatory philosophy, is generally rejected in the United States because it usually mandates establishment of safety as a matter of near certainty, something US risk analysts and risk managers generally view as impossible and undesirable. In addition, many US analysts view the precautionary principle as a de facto trade barrier, and in violation of the World Trade Organization's (WTO) Sanitary and Phytosanitary (SPS) and Technical Barriers to Trade (TBT) Agreements.
Depending upon the enforcement of the eventual regime by the individual member states, these developments could either streamline a process that has been in need of repair for some time, or it could become the source of yet another irritation between the US and the EU in the already volatile food and agribusiness trade sector.
Mark Mansour is a partner with Foley & Lardner LLP and a member of the firm's Public Affairs and International Practices, as well as the Food and Nanotechnology Industry Teams. He can be reached at 202.672.5585 or by e-mail at mmansour@foley.com.