1.The procedure for authorising the placing on the market within the Union of a novel food and updating of the Union list provided for in Article 9 shall start either on the Commission's initiative or following an application to the Commission by an applicant. The Commission shall make the application available to the Member States without delay. The Commission shall make the summary of the application, based on the information referred to in points (a), (b) and (e) of paragraph 2 of this Article, publicly available.
2.The application for an authorisation shall include:
(a)the name and address of the applicant;
(b)the name and description of the novel food;
(c)the description of the production process(es);
(d)the detailed composition of the novel food;
(e)scientific evidence demonstrating that the novel food does not pose a safety risk to human health;
(f)where appropriate, the analysis method(s);
(g)a proposal for the conditions of intended use and for specific labelling requirements which do not mislead the consumer or a verifiable justification why those elements are not necessary.
3.Upon request by the Commission, the European Food Safety Authority (‘the Authority’) shall give its opinion as to whether the update is liable to have an effect on human health.
4.When test methods are applied to engineered nanomaterials as referred to in points (a) (viii) and (ix) of Article 3(2), an explanation shall be provided by the applicants of their scientific appropriateness for nanomaterials and, where applicable, of the technical adaptations or adjustments that have been made in order to respond to the specific characteristics of those materials.
5.The procedure for authorising the placing on the market within the Union of a novel food and updating the Union list as provided for in Article 9 shall end with the adoption of an implementing act in accordance with Article 12.
6.By way of derogation from paragraph 5, the Commission may terminate the procedure at any stage, and decide not to proceed with an update, where it considers that such an update is not justified.
In such cases, where applicable, the Commission shall take account of the views of Member States, the Authority's opinion and any other legitimate factors relevant to the update under consideration.
The Commission shall inform the applicant and all Member States directly of the reasons for not considering the update to be justified. The Commission shall make the list of such applications publicly available.
7.The applicant may withdraw its application at any time, thereby terminating the procedure.
1.Where the Commission requests an opinion from the Authority, it shall forward the valid application to the Authority without delay, and not later than one month after having verified its validity. The Authority shall adopt its opinion within nine months from the date of receipt of a valid application.
2.In assessing the safety of novel foods, the Authority shall, where appropriate, consider whether:
(a)the novel food concerned is as safe as food from a comparable food category already placed on the market within the Union;
(b)the composition of the novel food and the conditions of its use do not pose a safety risk to human health in the Union;
(c)a novel food, which is intended to replace another food, does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
3.The Authority shall forward its opinion to the Commission, to the Member States and, where applicable, to the applicant.
4.In duly justified cases, where the Authority requests additional information from the applicant, the nine-month period provided for in paragraph 1 may be extended.
After consulting the applicant, the Authority shall specify a period within which that additional information is to be provided and shall inform the Commission thereof.
Where the Commission does not object to the extension within eight working days of being informed by the Authority, the nine-month period provided for in paragraph 1 shall be automatically extended by that additional period. The Commission shall inform the Member States of that extension.
5.Where the additional information referred to in paragraph 4 is not provided to the Authority within the additional period referred to in that paragraph, the Authority shall draw up its opinion on the basis of the available information.
6.Where an applicant submits additional information on its own initiative, it shall send that information to the Authority.
In such cases, the Authority shall give its opinion within the nine-month period provided for in paragraph 1.
7.The Authority shall make the additional information provided in accordance with paragraphs 4 and 6 available to the Commission and to the Member States.
1.Within seven months from the date of publication of the Authority's opinion, the Commission shall submit to the committee referred to in Article 30(1) a draft implementing act authorising the placing on the market within the Union of a novel food and updating the Union list, taking into account the following:
(a)the conditions provided for in points (a) and (b) of Article 7 and, where applicable, in point (c) of that Article;
(b)any relevant provision of Union law, including the precautionary principle as referred to in Article 7 of Regulation (EC) No 178/2002;
(c)the Authority's opinion;
(d)any other legitimate factors relevant to the application under consideration.
That implementing act shall be adopted in accordance with the examination procedure referred to in Article 30(3).
2.Where the Commission has not requested an opinion from the Authority in accordance with Article 10(3), the seven-month period provided for in paragraph 1 of this Article shall start from the date on which a valid application is received by the Commission in accordance with Article 10(1).
By 1 January 2018, the Commission shall adopt implementing acts concerning:
the content, drafting and presentation of the application referred to in Article 10(1);
the arrangements for verifying the validity, without delay, of those applications;
the type of information to be included in the opinion of the Authority referred to in Article 11.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(3).
Instead of following the procedure referred to in Article 10, an applicant, who intends to place on the market within the Union a traditional food from a third country, may opt to submit a notification of that intention to the Commission.
The notification shall include the following information:
the name and address of the applicant;
the name and description of the traditional food;
the detailed composition of the traditional food;
the country or countries of origin of the traditional food;
documented data demonstrating the history of safe food use in a third country;
a proposal for the conditions of intended use and for specific labelling requirements, which do not mislead the consumer, or a verifiable justification why those elements are not necessary.
1.The Commission shall forward the valid notification provided for in Article 14 without delay, and not later than one month after having verified its validity, to the Member States and to the Authority.
2.Within four months from the date on which a valid notification is forwarded by the Commission in accordance with paragraph 1, a Member State or the Authority may submit to the Commission duly reasoned safety objections to the placing on the market within the Union of the traditional food concerned.
3.The Commission shall inform the applicant of any duly reasoned safety objection as soon as it is submitted. The Member States, the Authority and the applicant shall be informed of the outcome of the procedure referred to in paragraph 2.
4.Where no duly reasoned safety objections have been submitted in accordance with paragraph 2 within the time-limit laid down in that paragraph, the Commission shall authorise the placing on the market within the Union of the traditional food concerned and update the Union list without delay.
The entry in the Union list shall specify that it concerns a traditional food from a third country.
Where applicable, certain conditions for use, specific labelling requirements, or post-market monitoring requirements shall be specified.
5.Where duly reasoned safety objections have been submitted to the Commission in accordance with paragraph 2, the Commission shall not authorise the placing on the market within the Union of the traditional food concerned or update the Union list.
In that case, the applicant may submit an application to the Commission in accordance with Article 16.
Where the Commission, acting in accordance with Article 15(5), does not authorise the placing on the market within the Union of a traditional food from a third country or update the Union list, the applicant may submit an application including, in addition to the information already provided in accordance with Article 14, documented data relating to the duly reasoned safety objections submitted in accordance with Article 15(2).
The Commission shall, without delay, forward the valid application to the Authority and make it available to Member States.
1.The Authority shall adopt its opinion within six months from the date of receipt of a valid application.
2.In assessing the safety of a traditional food from a third country, the Authority shall consider the following matters:
(a)whether the history of safe food use in a third country is substantiated by reliable data submitted by the applicant in accordance with Articles 14 and 16;
(b)whether the composition of the food and the conditions of its use do not pose a safety risk to human health in the Union;
(c)where the traditional food from the third country is intended to replace another food, whether it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
3.The Authority shall forward its opinion to the Commission, the Member States and the applicant.
4.In duly justified cases, where the Authority requests additional information from the applicant, the six-month period provided for in paragraph 1 may be extended.
After consulting the applicant, the Authority shall specify a period within which that additional information is to be provided and shall inform the Commission thereof.
Where the Commission does not object to the extension within eight working days of being informed by the Authority, the six-month period provided for in paragraph 1 shall be automatically extended by that additional period. The Commission shall inform the Member States of that extension.
5.Where the additional information referred to in paragraph 4 is not provided to the Authority within the additional period referred to in that paragraph, the Authority shall draw up its opinion on the basis of the available information.
6.Where an applicant submits additional information on its own initiative, it shall send that information to the Authority.
In such cases, the Authority shall give its opinion within the six-month period provided for in paragraph 1.
7.The Authority shall make the additional information provided in accordance with paragraphs 4 and 6 available to the Commission and to Member States.
1.Within three months of the date of publication of the Authority's opinion, the Commission shall submit to the committee referred to in Article 30(1) a draft implementing act authorising the placing on the market within the Union of the traditional food from a third country and updating the Union list, taking into account the following:
(a)the conditions provided for in points (a) and (b) of Article 7 and, where applicable, point (c) of that Article;
(b)any relevant provision of Union law, including the precautionary principle as referred to in Article 7 of Regulation (EC) No 178/2002;
(c)the Authority's opinion;
(d)any other legitimate factors relevant to the application under consideration.
That implementing act shall be adopted in accordance with the examination procedure referred to in Article 30(3).
2.By way of derogation from paragraph 1, the Commission may terminate the procedure at any stage and decide not to proceed with an update where it considers that such an update is not justified.
In such case, where applicable, the Commission shall take account of the views of Member States, the Authority's opinion and any other legitimate factors relevant to the update under consideration.
The Commission shall inform the applicant and all Member States directly of the reasons for not considering the update to be justified.
3.The applicant may withdraw its application referred to in Article 16 at any time, thereby terminating the procedure.
Articles 10 to 13 apply to removing a traditional food from a third country from the Union list or to adding, removing or changing specifications, conditions of use, additional specific labelling requirements or post-market monitoring requirements associated with the inclusion of a traditional food from a third country on the Union list.
By 1 January 2018 the Commission shall adopt implementing acts concerning:
the content, drafting and presentation of the notifications referred to in Article 14 and of applications referred to in Article 16;
the arrangements for verifying the validity, without delay, of those notifications and applications;
the arrangements for the exchange of information with the Member States and with the Authority for submitting duly reasoned safety objections as referred to in Article 15(2);
the type of information to be included in the opinion of the Authority referred to in Article 17.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(3).