Chemically defined flavouring substances

Flavouring substances used in food are included in a list which is valid throughout the European Union (EU). The procedure for evaluation of these substances is harmonised, as are the general criteria for use. The Member States propose new substances which will be evaluated.

ACT

Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 1996 laying down a Community procedure for flavouring substances used or intended for use in or on foodstuffs [See amending acts].

SUMMARY

Flavouring substances are used by the food industry to give a taste or flavour to foodstuffs.

Regulation (EC) No 2232/96 lays down the procedure to be followed for the authorisation of chemically defined flavouring substances *.

Authorisation procedure. List of flavouring substances

The Member States submit to the European Commission a list of the flavouring substances which may be used in foodstuffs marketed on their territory.

This list includes all information on:

• the nature(for example the chemical formula), origin and purity of these substances;
• the foods in which these substances are chiefly used;
• compliance with the criteria for substance conformity and the reasons for their use.

The Commission evaluates the notified substance within one year. An appropriate toxicological evaluation must show that the substance does not pose any health risks. Other criteria are also taken into account, for example the substance must not mislead the consumer.

Only after this procedure will the substance be authorised and included in the list of authorised substances, which is valid for the whole of the European Union. The Member States may not obstruct or prohibit the free movement of foodstuffs containing authorised substances. This list will be established by 31 October 2009, in accordance with Regulation (EC) No 1334/2008. There is currently no Community list, only a register which was used as a basis for the launch of the evaluation programme. This Regulation will be repealed as soon as the list is adopted and included in Regulation (EC) No 1334/2008.

The substances on the list are designated in such a way as to protect the intellectual property rights of their manufacturer.

The list is open-ended and may be amended by removing or adding authorised substances.

Safeguard clause

If one Member State notes that a substance on the register may constitute a danger to public health, it must notify the Commission and the other Member States before suspending or restricting its use. The Commission evaluates the measure taken by the Member State and may if necessary decide to amend the register of substances, following consultation with a regulatory committee.

Evaluation of criteria

Within ten months of the adoption of the register the Commission adopts an evaluation programme which defines:

• the order of priorities according to which the substances are to be examined;
• the time limits;
• the substances which are to be the subject of scientific cooperation.

If the evaluation reveals that one of the substances does not comply with the use criteria, that substance will be deleted from the register (see below, evaluation programme, Regulation (EC) No 622/2002).

RELATED ACTS

Register of flavouring substances

Commission Decision 1999/217/EC of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council [Official Journal L 84 of 27.03.1999].See consolidated version (pdf)

Evaluation programme

Regulation (EC) No 622/2002 [Official Journal L 95 of 12.04.2002]. The purpose of this Regulation is to rationalise and facilitate the evaluation of substances by making additions to the evaluation programme and establishing deadlines for Member States to submit the necessary information.

Commission Regulation (EC) No 1565/2000 of 18 July 2000 laying down the measures necessary for the adoption of an evaluation programme in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council [Official Journal L 180 of 19.07.2000]

Protection of intellectual property

Communication on the ways in which the Commission is to protect intellectual property linked to the development and manufacture of flavouring substances covered by Regulation (EC) No 2232/96 of the European Parliament and of the Council [Official Journal C 131 of 29.04.1998].

Commission Recommendation 98/282/EC of 21 April 1998 on the ways in which the Member States and the signatory States to the Agreement on the European Economic Area should protect intellectual property linked to the development and manufacture of flavouring substances referred to in Regulation (EC) No 2232/96 of the European Parliament and of the Council [Official Journal L 127 of 29.04.1998].

Last updated: 12.02.2009