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Document 31997R0258
New (novel) foods and food ingredients
This summary has been archived and will not be updated. See 'New (novel) foods — rules from 2018' for an updated information about the subject.
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?
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:
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:
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:
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