Regulatory round-up 2006

Health and nutritional claims regulation​

The contentious health and nutrition claims regulation was finally adopted in October - the product of a compromise deal between the Parliament and the Council, which had wildly different views on certain key points - such as authorisation versus notification procedure, and nutrient profiling.

The regulation is published in the official journal of the EC this month, and will become applicable in six months time.

Even once the compromise had been struck in May, however, the regulation was beleagued by hitches. For instance, just prior to its planned adoption (September), it was discovered to contain the wrong comitology procedure. The procedure by which enacting periods or amendments are drawn up in full had been changed in July, but the regulation was not changed to reflect this.

The decision was made to go ahead and adopt the regulation anyway, and amend it with the correct procedure as soon as possible. The amendment is due for vote in Parliament in early 2007, and is slated for publication in March/April.

Discussions have already begun over enforcement of the regulation. For instance, national food safety authorities have begun compiling their lists of proposed well-established claims. Member states must submit their lists by early 2008, after which the final list will be drawn up within two years.

Claims for which the science is less decisive or on which more research emerges will be subject to assessment and approval by EFSA. Although EFSA has said it is welcoming more work in the area of nutrition, there is some anxiety about resources and the five-month timescale it will have to hand down its decision.

At a conference held in Bologne in November Herman Koëter, EFSA director of science, said that that there will be no problem if submissions are received one-by-one - but if it receives a high number at the same time it will have difficulty meeting the deadline.

Companies, for their part, are being strongly urged to start preparing for the legislation, to avoid having to withdraw claim-bearing products at the last minute if they do not make it onto EFSA's list.

Speaking at the Healthy Foods Summit in London at the end of October, Guy Valkenborg, director of European Advisory Services said they should:

Ensure that all new claims are in line with the regulations; assess the impact on claims already on the market; ensure there is adequate scientific basis for all claims; prepare and submit the appropriate dossiers where required.

Fortified foods regulation​

The fortified foods regulation was adopted in the summer, and enters into force this month on publication in the official journal. It will become applicable in six months' time.

It is also to be amended with the new comitology procedure early next year.

The regulation is concerned only with fortification of food products on the initiative of manufacturers; mandatory fortification of certain foods (such as flour with folic acid) remains the bailiwick of member states' own regulatory bodies.

Although far less contentious in its main thrust than the health and nutrition claims regulation, it does require the setting of maximum levels of vitamins and minerals for products sold in all member states.

Vitamin and mineral levels​

Maximum levels for vitamins and mineral are to be set as part of the fortified foods regulation and the 2002 food supplements directive. They are intended to aid trade, and create a level playing field.

The levels have proved a hot topic of debate, as there are a multitude of different models - both currently employed by member states and proposed. While Germany is one of the most restrictive markets, with higher dose products subject to regulation as medicines, The Netherlands and the UK are amongst the most lenient.

Discussions began in earnest over the best way to set maximum levels across member states in June with the publication of the EC discussion paper, which included a number of suggested models.

Stakeholders were invited to respond to a number of questions, and the first summary of responses was presented last month at a conference organised by trade associations ERNA and EHPM.

Although some disagreements remained over issues such as the feasibility of a two-tier system (proposed by the UK) and whether minor adverse effects are acceptable, by-and-large the day progressed without thundering disagreements.

The next stage in the process is to make a proposal that would then be discussed with Member States. There is not yet any indication of a timescale for a final decision on the matter, but many people believe it could be as long as two years before it is closed.