www.checkbiotech.org ; www.raupp.info ; www.czu.cz

New measures adopted by the European Commission designed to streamline the
approval of additives, colors, flavorings and enzymes, could result in
longer approval procedures for US exporters, with some presently approved
ingredients potentially restricted in the future, according to a US lawyer,
November 2006 by Mark Mansour, Foley & Lardner.

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.

[www.checkbiotech.org]

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