New (novel) foods and food ingredients

SUMMARY OF:

Regulation (EC) No 258/97 concerning novel foods and novel food ingredients

SUMMARY

WHAT DOES THIS DIRECTIVE DO?

• It seeks to harmonise the rules for authorising novel foods and food ingredients at EU level.
• It requires that tests are carried out by the European Food Safety Authority to demonstrate that these products do not pose any risk to health or the environment.

KEY POINTS

The novel foods and food ingredients concerned by this regulation are those which are not yet currently used for human consumption.

Novel foods and food ingredients

This regulation applies to foods and food ingredients in the following categories:

• foods and food ingredients which present a new or modified primary molecular structure;
• foods and food ingredients which consist of micro-organisms, fungi or algae;
• foods and food ingredients which consist of or are isolated from plants and ingredients isolated from animals;
• foods and food ingredients whose nutritional value, metabolism or level of undesirable substances has been significantly changed by the production process.

The regulation does not apply to food additives, flavourings, extraction solvents, or to food enzymes. Genetically modified organisms are no longer covered by this regulation, but by Regulation (EC) No 1823/2003 instead.

Furthermore, foods and food ingredients covered by this regulation must not:

• present a danger for the consumer;
• mislead the consumer;
• be nutritionally disadvantageous for the consumer.

Evaluation procedure

The foods and food ingredients referred to in the regulation must undergo EU assessment before being placed on the market.

Under the assessment procedure, the competent body of the EU country which receives an application must make an initial assessment and determine whether or not an additional assessment is required. If neither the European Commission nor EU countries raise an objection, and if no additional assessment is required, the EU country informs the applicant that he/she may place the product on the market. In other cases, an authorisation decision is required. This decision is adopted in accordance with the measures proposed by the Commission by the European Food Safety Authority (EFSA).

The decision defines the scope of the authorisation and specifies (as appropriate) the conditions of use, the designation of the food or food ingredient, its specification and the specific labelling requirements.

Any decision or rule concerning a novel food or food ingredient which is likely to have an effect on public health must be referred to EFSA.

Labelling

The regulation lays down specific requirements concerning the labelling of novel food and food ingredients which have been added to the European general requirements on food labelling.

Without prejudice to the general requirements of EU legislation concerning the labelling of foodstuffs, the labelling of novel food and food ingredients must mention:

• any characteristics such as composition, nutritional value or the intended use of the foodstuff;
• the presence of materials which may have implications for the health of some individuals;
• the presence of materials which give rise to ethical concerns.

Suspension procedure

EU countries are authorised to suspend or restrict — provisionally — the marketing and use in their territory of any novel food or food ingredient, if they believe that its use constitutes a health hazard or a risk to the environment. They inform the Commission, which takes steps in accordance with the procedure regarding authorisations for placing products on the market.

Repeal

Regulation (EU) 2015/2283 repeals Regulation (EC) No 258/97 from 1 January 2018.

FROM WHEN DOES THIS REGULATION APPLY?

It has applied since 14 May 1997.

BACKGROUND

For more information, see ‘Novel food’ on the European Commission’s website

ACT

Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, pp. 1-6).

Subsequent amendments to Regulation (EC) No 258/97 have been incorporated into the basic text. This consolidated version is of documentary value only.

RELATED ACTS

Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, pp. 1-22)

last update 18.04.2016