Next event: Final act published in Official Journal 2015/12/11 more...
- Commission response to text adopted in plenary 2015/12/10
- Draft final act 2015/11/25
- Final act signed 2015/11/25
- End of procedure in Parliament 2015/11/25
- Coreper letter confirming interinstitutional agreement 2015/11/16
- Text agreed during interinstitutional negotiations 2015/11/16
- Act adopted by Council after Parliament's 1st reading 2015/11/16
- Council Meeting 2015/11/16
- Results of vote in Parliament 2015/10/28
- Debate in Parliament 2015/10/28
- Decision by Parliament, 1st reading 2015/10/28
- Approval in committee of the text agreed at 1st reading interinstitutional negotiations 2015/06/24
Progress: Procedure completed
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Lead | ENVI | NICHOLSON James ( ECR) | AYUSO Pilar ( PPE), POC Pavel ( S&D), PAULSEN Marit ( ALDE), STAES Bart ( Verts/ALE), EVI Eleonora ( EFDD) |
Former Responsible Committee | ENVI | ||
Committee Opinion | INTA | KIRTON-DARLING Jude ( S&D) | |
Committee Opinion | AGRI | SÂRBU Daciana Octavia ( S&D) | |
Committee Opinion | ITRE | ||
Committee Opinion | IMCO | ||
Former Committee Opinion | IMCO | ||
Former Committee Opinion | INTA | José BOVÉ ( Verts/ALE), Marielle DE SARNEZ ( ALDE), Santiago FISAS AYXELÀ ( PPE), Emma McCLARKIN ( ECR), Anne-Marie MINEUR ( GUE/NGL) | |
Former Committee Opinion | AGRI | Angélique DELAHAYE ( PPE), Giulia MOI ( EFDD) | |
Former Committee Opinion | ITRE |
Lead committee dossier:
Legal Basis:
TFEU 114
Legal Basis:
TFEU 114Subjects
Events
PURPOSE: to lay down rules for the placing of novel foods on the market within the Union while providing a high level of protection of human health.
LEGISLATIVE ACT: Regulation (EU) 2015/2283 of the European Parliament and of the Council 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.
CONTENT: this Regulation lays down rules for the placing of novel foods on the market within the Union. The purpose of this Regulation is to ensure the effective functioning of the internal market while providing a high level of protection of human health and consumers' interests.
Scope : ‘novel food’ shall mean any food that was not used for human consumption to a significant degree within the Union before 15 May 1997, irrespective of the dates of accession of Member States to the Union. However, on the basis of scientific and technological developments that have occurred since 1997, the Regulation reviews, clarifies and updates the categories of food which constitute novel foods .
The following are considered as novel foods under this Regulation:
food with a new or intentionally modified molecular structure ; food consisting of, isolated from or produced from microorganisms, fungi or algae or from material of mineral origin, cell culture or tissue culture derived from animals; food from plants obtained by non-traditional propagating practices where those practices give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances; food consisting of engineered nanomaterials ; vitamins, minerals and other substances used in accordance with Directive 2002/46/EC , Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013 , where: food used exclusively in food supplements within the Union before 15 May 1997, where it is intended to be used in foods other than food supplements.
Animal clones : until specific legislation on food from animal clones enters into force, food from animal clones should fall under the scope of this Regulation as food from animals obtained by non-traditional breeding practices and should be appropriately labelled for the final consumer in accordance with the Union legislation in force.
Procedure for determination of novel food status : in order to determine whether or not a food falls within the scope of this Regulation, Member States may consult the other Member States and the Commission . The Commission may decide, on its own initiative or upon a request by a Member State, by means of implementing acts, whether or not a particular food falls within the definition of novel food.
Placing novel food on the market : only novel foods authorised and included in the Union list, established by the Commission, may be placed on the market within the Union. The Commission shall only authorise and include a novel food in the Union list if it complies with the following conditions:
the food does not, on the basis of the scientific evidence available, pose a safety risk to human health; the food's intended use does not mislead the consumer , especially when the food is intended to replace another food and there is a significant change in the nutritional value; where the food is intended to replace another food , it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
Authorisation procedure : the procedure for authorising the placing on the market within the Union of a novel food and updating of the Union list shall be efficient, time-limited and transparent . It 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.
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.
Opinion of the Authority : the Commission and the Authority must respect certain time limits in order to ensure the harmonious treatment of applications for authorisation. However, in certain cases, the Commission and the Authority may extend the time limits.
The Commission shall forward the valid notification without delay, and not later than one month after having verified its validity, to the Member States and to the Authority.
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.
Within seven months from the date of publication of the Authority's opinion, the Commission shall submit a draft implementing act authorising the placing on the market within the Union of a novel food and updating the Union list.
Traditional foods from third countries : the placing on the market within the Union of traditional foods from third countries should be facilitated where the history of safe food use in a third country has been demonstrated. Those foods should have been consumed in at least one third country for at least 25 years as a part of the customary diet of a significant number of people. The history of safe food use should not include non-food uses or uses not related to normal diets.
Data protection : in order to stimulate research and development within the agri-food industry, and thus innovation, it is appropriate to protect the investment made by the applicants in gathering the information and data provided in support of an application for a novel food made in accordance with this Regulation.
The Regulation stipulates that on request by the applicant, and where supported by appropriate and verifiable information included in the application, newly developed scientific evidence or scientific data supporting the application shall not be used for the benefit of a subsequent application during a period of five years from the date of the authorisation of the novel food without the agreement of the initial applicant.
ENTRY INTO FORCE: 31.12.2015.
APPLICATION: from 01.01.2018 with the exception of certain provisions which shall apply from 31.12.2015 or from the date of application of certain implementing acts.
DELEGATED ACTS: the power to adopt delegated acts should be delegated to the Commission in respect of the adjustment and adaptation of the definition of engineered nanomaterial to technical and scientific progress or to definitions agreed at international level. It shall be conferred on the Commission for a period of five years (renewable) from 31 December 2015. The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification (this period may be extended by two months). If the European Parliament or the Council objects, the delegated act shall not enter into force.
The European Parliament adopted by 359 votes to 202 with 127 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on novel foods.
Parliament’s position adopted in first reading following the ordinary legislative procedure amends the Commission proposal as follows:
Purpose and scope : Parliament specified that the purpose of the Regulation is to ensure the effective functioning of the internal market while providing a high level of protection of human health and consumers' interests.
In order to adapt the Regulation to scientific and technological developments that have occurred since 1997, Parliament adopted amendments to review, clarify and update the categories of food which constitute novel foods. These categories should include:
food with a new or intentionally modified molecular structure , where that structure was not used as, or in, a food within the Union before 15 May 1997; food consisting of, isolated from or produced from microorganisms, fungi or algae; food consisting of, isolated from or produced from material of mineral origin; food from plants obtained by non-traditional propagating practices where those practices give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances; food consisting of, isolated from or produced from animals or their parts , except for animals obtained by traditional breeding practices which have been used for food production within the Union before 15 May 1997 and the food from those animals has a history of safe food use within the Union; food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae; food containing engineered nanomaterials as defined in the Regulation.
In order to determine whether or not a food falls within the scope of the Regulation, Member States may consult the other Member States and the Commission .
The Commission may decide, on its own initiative or upon a request by a Member State, by means of implementing acts , whether or not a particular food falls within the definition of novel food.
Union list: only novel foods authorised and included in the Union list may be placed on the market within the Union as such, or used in or on foods, in accordance with the conditions of use and the labelling requirements specified therein.
Parliament specified that the Commission shall only authorise and include a novel food in the Union list if the food's intended use does not mislead the consumer , especially when the food is intended to replace another food and there is a significant change in the nutritional value.
Updating of the Union list may consist of, inter alia, adding, removing or changing the specifications, conditions of use, additional specific labelling requirements or post-market monitoring requirements associated with the inclusion of a novel food in the Union list.
With regard to the placing on the market within the Union of a traditional food from a third country, the entry in the Union list shall specify that it concerns a traditional food from a third country.
Authorisation procedure : the Commission and the Authority must respect certain time limits in order to ensure the harmonious treatment of applications for authorisation. However, in certain cases, the Commission and the Authority may extend the time limits.
The Commission shall make the application available to the Member States without delay and make the summary of the application publicly available.
The application for an authorisation shall include the name and address of the applicant; the description of the production process; the detailed composition of the novel food; and where appropriate, the analysis method(s).
Upon request by the Commission, the European Food Safety Authority shall give its opinion as to whether the update is liable to have an effect on human health.
When test methods are applied to engineered nanomaterials , the applicants shall provide an explanation of their scientific appropriateness for nanomaterials
Opinion of the Authority : 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.
Within seven months from the date of publication of the Authority's opinion, the Commission shall submit a draft implementing act authorising the placing on the market within the Union of a novel food and updating the Union list
Authorisation procedure in case of a parallel application for the authorisation of a health claim : the amended text states that on request by the applicant, the Commission shall stay an authorisation procedure for a novel food started following an application, where the applicant has submitted: (i) a request for data protection; and (ii) an application for the authorisation of a health claim on the same novel food in accordance with Regulation (EC) No 1924/2006, in conjunction with a request for data protection.
The Commission shall inform the applicant about the date of effect of the stay. The authorisation procedure shall resume when the Commission has received the opinion of the Authority on the health claim. The Commission shall inform the applicant about the date of resumption of the authorisation procedure.
Cloned animals : until specific legislation on food from animal clones enters into force, food from animal clones should fall under the scope of this Regulation as food from animals obtained by non-traditional breeding practices and should be appropriately labelled for the final consumer in accordance with the Union legislation in force.
The Committee on the Environment, Public Health and Food Safety adopted the report by James NICHOLSON (ECR, UK) on the proposal for a regulation of the European Parliament and of the Council on novel foods.
The committee recommended that Parliament’s position adopted in first reading following the ordinary legislative procedure should amend the Commission proposal as follows :
Purpose and scope : Members stated that the primary objective of the Regulation should be to ensure a high level of protection of human health, consumers’ interests and of the environment and the effective functioning of the internal market.
In order to adapt the Regulation to technological progress and new kinds of food entering the Union marketplace, Members adopted amendments aiming to reintroduce food categories and introduce new categories for:
· food with a new or intentionally modified primary molecular structure;
· food containing, consisting of, or produced from microorganisms, fungi and algae;
· new foods containing, consisting of, or produced from plants or animals;
· food derived from cloned animals or their descendants ;
· food containing, consisting of, or obtained from cellular or tissue cultures.
Marketing of novel foods in the Union: food business operators shall consult the Member State in which they first intend to place the novel food. They shall provide the necessary information to the Member State to enable it to determine whether or not a food falls within the scope of the Regulation. With a view to determining that assessment, the Member State may consult the Commission and other Member States.
Union list : the Commission shall only authorise a novel food in the Union list if: (a) it does not pose a safety risk to human health, nor to animal welfare and where applicable to the environment; (ii) its intended use, presentation and labelling do not mislead the consumer, especially when there is a significant change in the nutritional value of a food intended to replace another food; (iii) it is possible to ensure the traceability of the materials used in its manufacture.
Foods to which production processes have been applied that require specific risk assessment methods (for example, foods produced using nanotechnologies) may not be included in the Union list until such specific methods have been approved by EFSA for use.
Streamlining the authorisation procedure : Members were concerned that the Commission’s proposals did not go far enough in reducing the delays applicants might face. One amendment stated that the Commission should make the application available to Member States without delay and verify the validity of the application within one month of receipt of the latter. Where the Commission requested an opinion from EFSA, it should forward a valid novel food application to EFSA within one month, rather than an unspecified period of time.
The Commission will be empowered to adopt delegated acts in order to update the list of novel foods within six months from EFSA giving its opinion.
In general, the extensions of time limits should be exceptional and appropriate. The applicant is to be the first to be informed about the extension.
Data protection : Members wanted to specify that if an applicant requested data protection on the same food both under this Regulation and Regulation (EC) 1924/2006 , the Commission should endeavour to align the timing of both authorisation procedures to let the data protection periods run concurrently. In addition to this alignment of intellectual property protection periods, health claim and novel food evaluation and authorisation procedures shall, where possible, also be synchronised.
Under the Commission proposal, an applicant could obtain protection for data for five years for innovative products. Members want this period to be seven years from the date of authorisation of the novel food.
Monitoring : the Commission shall, for food safety reasons and in line with the precautionary principle impose a requirement for postmarked monitoring for all novel food, in order to ensure that the use of the authorised novel food is within safe limits.
Migration limits for constituents of food contact materials : as the Regulation deals with nanomaterials in food, Members stressed that it was important to ensure that nanoparticles that might accidentally migrate into food be taken into account.
Privileges of Member States : where a Member State had detailed grounds for considering that the use of a food complying with the Regulation endangered human health or the environment, that Member State might either temporarily restrict or suspend the trade in that food in its territory.
Cloned animals : until specific legislation on food derived from cloned animals and their descendants entered into force, this food should be accompanied by the following information for the final consumer: "Food derived from cloned animals/descendants of cloned animals."
PURPOSE : to ensure food safety, to protect public health and secure the functioning of the internal market for food, while supporting innovation for the food sector.
PROPOSED ACT : Regulation of the European Council and of the Parliament.
ROLE OF THE EUROPEAN PARLIAMENT : the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND : Union rules on novel foods were set out in Regulation (EC) n° 258/97 of the European Parliament and Council and Commission Regulation (EC) n° 1852/2001. Those rules need to be updated to simplify the current authorisation procedures and to take account of recent developments in Union law.
In January 2008, the Commission adopted a proposal aiming to simplify the authorization procedure set out in Regulation (EC) 258/97 on novel foods. The legislative discussions under the ordinary legislative procedure mainly focused on the provisions applicable to: (i) nanomaterials; (ii) the cloning of animals for food production; (iii) traditional foods from third countries; (iv) the criteria to be examined for the risk assessment, and (v) risk management and to the procedure for the authorisation of novel foods in accordance with the Treaty on the Functioning of the European Union (Lisbon Treaty).
However, the proposal was not adopted after the Conciliation Committee failed to reach an agreement in March 2011.
The Commission considers that issues related to cloning of farm animals should be addressed in a separate proposal , based on an impact assessment.
IMPACT ASSESSMENT : the 2008 impact assessment is still valid, and the rationale for an in-depth revision of the current legislation remains unchanged (the length and cost of the current authorisation procedure, the need for a centralised risk assessment and risk management and for an adjusted procedure for the placing on the EU market of traditional foods from third countries).
CONTENT : the proposal brings together and updates the provisions of the legislation currently in force, which will be repealed at the time of entry into application of the new legislation. It aims to streamline the authorisation procedure for novel foods , to improve its efficiency and transparency. It is limited to the safety of novel food and is based on the overall agreement achieved in conciliation.
The main points are as follows:
Subject matter, scope and definitions
· novel foods will be subject to safety evaluation and authorisation through a fully harmonised procedure;
· the definition of novel foods is clarified, bearing in mind new technologies which have an impact on food.
· a simplified procedure is created for marketing of traditional foods from third countries;
· nanomaterials which are intended for food uses and covered by the definition of "engineered nanomaterials", as laid down in Regulation (EU) n°1169/2011 on food information to consumers, shall be assessed and authorised under this Regulation before being placed on the EU market.
Requirements for placing novel foods on the market within the Union:
· all novel foods and their use must not present a danger to human health and their use should not mislead the consumer;
· for every authorised novel food, specifications, labelling requirements, conditions of use and, where appropriate, a requirement of post-market monitoring may be laid down;
· the current system of individual authorisations is replaced by a system of generic authorisation;
· novel foods already authorised shall continue to be marketed and will be included in the Union list of novel foods.
Authorisation procedure for a novel food
· all applications for the authorisation of novel foods shall be submitted to the Commission which may then request a scientific opinion on risk assessment from the European Food Safety Authority (EFSA);
· the inclusion of a novel food in the Union list of novel foods will be considered by the Commission on the basis of the opinion from EFSA.
For traditional foods from third countries , a safety assessment and a risk management, based on a history of safe food use, is introduced:
· if the applicant has shown a history of safe food use in a third country for at least 25 years, and if the Member States or EFSA do not present reasoned safety objections based on scientific evidence, the food may be included in the Union list;
· where reasoned safety objections are presented, an EFSA assessment followed by an EU authorisation procedure, similar to the standard authorisation procedure but with shorter deadlines, is required.
Additional procedural rules and other requirements
· the information provided by the applicant should be kept confidential where the disclosure of such information might significantly harm their competitive position.
Data protection
· in order to support innovation in the EU food industry and only in duly justified cases, individual authorisations with data protection may be granted for a maximum period of five years.
Penalties and committee procedure
· rules on penalties applicable to infringements of the provisions of the proposed Regulation will be laid down;
· implementation of the measures proposed in the Regulation will be mainly adopted by the Commission. This relates to the conditions of use and labelling of a novel food as well as laying down specifications and, where appropriate post-market monitoring requirements.
Transitional provisions
· transitional measures are set out to ensure a smooth transition with on-going applications and notifications, pending the entry into application of this legislation;
· to enhance legal certainty, a food that was legally placed on the market prior to the application of this Regulation, should be allowed to be continued to be marketed until the risk assessment and authorisation procedures have been concluded.
BUDGETARY IMPLICATIONS : operational resources necessary for implementation of the proposal will be covered by redeployment within the contribution granted to EFSA during the annual budgetary procedure.
The estimated impact on appropriations of an administrative nature is EUR 2.750 million for the period 2014-2020.
Documents
- Final act published in Official Journal: Regulation 2015/2283
- Final act published in Official Journal: OJ L 327 11.12.2015, p. 0001
- Commission response to text adopted in plenary: SP(2015)750
- Draft final act: 00038/2015/LEX
- Coreper letter confirming interinstitutional agreement: GEDA/A/(2015)012870
- Text agreed during interinstitutional negotiations: PE610.569
- Results of vote in Parliament: Results of vote in Parliament
- Debate in Parliament: Debate in Parliament
- Decision by Parliament, 1st reading: T8-0380/2015
- Approval in committee of the text agreed at 1st reading interinstitutional negotiations: PE610.569
- Approval in committee of the text agreed at 1st reading interinstitutional negotiations: GEDA/A/(2015)012870
- Committee report tabled for plenary, 1st reading: A8-0046/2014
- Committee opinion: PE537.403
- Committee opinion: PE537.498
- Amendments tabled in committee: PE539.826
- Amendments tabled in committee: PE541.296
- Amendments tabled in committee: PE541.297
- Amendments tabled in committee: PE541.298
- Committee draft report: PE537.480
- Economic and Social Committee: opinion, report: CES0933/2014
- Contribution: COM(2013)0894
- Contribution: COM(2013)0894
- Contribution: COM(2013)0894
- Legislative proposal published: EUR-Lex
- Legislative proposal published: COM(2013)0894
- Economic and Social Committee: opinion, report: CES0933/2014
- Committee draft report: PE537.480
- Amendments tabled in committee: PE539.826
- Amendments tabled in committee: PE541.296
- Amendments tabled in committee: PE541.297
- Amendments tabled in committee: PE541.298
- Committee opinion: PE537.498
- Committee opinion: PE537.403
- Coreper letter confirming interinstitutional agreement: GEDA/A/(2015)012870
- Text agreed during interinstitutional negotiations: PE610.569
- Draft final act: 00038/2015/LEX
- Commission response to text adopted in plenary: SP(2015)750
- Contribution: COM(2013)0894
- Contribution: COM(2013)0894
- Contribution: COM(2013)0894
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Amendments | Dossier |
767 |
2013/0435(COD)
2014/10/10
INTA
97 amendments...
Amendment 100 #
Proposal for a regulation Article 22 – paragraph 4 – subparagraph 2 – point b (b) the name
Amendment 101 #
Proposal for a regulation Article 23 – title Post-market monitoring and changes to labelling requirements
Amendment 102 #
Proposal for a regulation Article 23 – paragraph 1 (1) The Commission may, for food safety reasons and with a view to guaranteeing transparency as regards the use of the novel food, on the basis of a properly substantiated request from a Member State or taking into account the opinion of EFSA, impose a requirement for post- market monitoring of a novel food or additional labelling requirements to ensure that the use of the authorised novel food is within safe limits and that transparency for consumers is guaranteed.
Amendment 103 #
Proposal for a regulation Article 23 – paragraph 2 – introductory part 2. The food business operators and the health authorities of the Member States shall forthwith inform the Commission of
Amendment 104 #
Proposal for a regulation Article 24 – paragraph 1 (1) On request by the applicant, supported by appropriate and verifiable information included in the application provided for in Article 9(1), newly developed scientific evidence or scientific data from independent sources supporting the application may not be used for the benefit of a subsequent application during a period of five years from the date of the authorisation and the inclusion of the novel food in the Union list without the agreement of the prior applicant.
Amendment 105 #
Proposal for a regulation Article 26 – paragraph 1 Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive and shall ensure a level playing field. Member States shall notify those provisions to the Commission by …26 at the latest and shall notify it without delay of any subsequent amendment affecting them. __________________ 26 Publications Office: please insert date: 24 months after the date of entry into force of this Regulation.
Amendment 106 #
Proposal for a regulation Article 26 – paragraph 1 Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented
Amendment 107 #
Proposal for a regulation Article 29 – paragraph 3 a (new) 3a. Until Council Directive XXX/XX/EU on [on the placing on the market of food from animal clones] enters into force, foods derived from cloned animals and their descendants shall not be authorised and/or placed on the Union list of novel foods authorised to be placed on the market within the Union.
Amendment 108 #
Proposal for a regulation Article 29 a (new) Article 29a Reporting Five years after entry into force and in the light of experience gained, the Commission shall forward to the European Parliament and to the Council a report on the implementation of this regulation and, in particular, of article 3 and 8, accompanied, where appropriate, by any proposal.
Amendment 109 #
Proposal for a regulation Article 29 b (new) Article 29b The report shall be made public.
Amendment 13 #
Proposal for a regulation Citation 1 Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 192 thereof,
Amendment 14 #
Proposal for a regulation Recital 1 (1) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, as well as benefitting their social and economic interests. Differences between national laws concerning the safety assessment and authorisation of novel foods may hinder the free movement of such food, thereby creating unfair conditions of competition including for agri-food industry and in particular for SMEs.
Amendment 15 #
Proposal for a regulation Recital 2 (2) A high level of protection of human health and of consumers’ interests, environmental friendliness, and
Amendment 16 #
Proposal for a regulation Recital 2 (2)
Amendment 17 #
Proposal for a regulation Recital 2 (2) A high level of protection of human health and of consumers’ interests and the effective functioning of the internal market should be assured in the pursuit of Union food policies, whilst ensuring transparency and stimulating innovation and creativity within the agri-food SMEs and applying the standards laid down in Union legislation to all food, including those imported from third countries.
Amendment 18 #
Proposal for a regulation Recital 2 a (new) (2a) The Union applies the precautionary principle in the areas of health and food.
Amendment 19 #
Proposal for a regulation Recital 2 a (new) (2a) In its Communication of 2 February 2000 the Commission stressed the importance of the precautionary principle.
Amendment 20 #
Proposal for a regulation Recital 4 (4) Foods which are intended to be used for technological purposes and genetically modified food or food from cloned animals should not fall within the scope of this Regulation as they are already covered by other Union rules. Therefore, genetically modified food falling within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council10, enzymes falling within the scope of Regulation (EC) No 1332/2008 of the European Parliament and of the Council11, food used solely as additives falling within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council12, flavourings falling within the scope of Regulation (EC) No 1334/2008 of the European Parliament and of the Council13
Amendment 21 #
Proposal for a regulation Recital 7 (7) Emerging technologies in food production processes
Amendment 22 #
Proposal for a regulation Recital 9 (9) When there is a significant change in the production process of a substance that has been used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013,
Amendment 23 #
Proposal for a regulation Recital 11 (11) The
Amendment 24 #
Proposal for a regulation Recital 11 (11) The placing on the market within the Union of traditional foods from third countries should be facilitated, where the history of safe food use in at least two third countr
Amendment 25 #
Proposal for a regulation Recital 11 (11) The placing on the market within the Union of traditional foods from third countries should be facilitated, where the history of safe food use in a third country has been demonstrated, in accordance with rules established by the EFSA. Those foods should have been consumed in a third country for at least 25 years as a part of the customary diet within a large part of the population of the country. The history of safe food use should not include non- food uses or uses not related to normal diets.
Amendment 26 #
Proposal for a regulation Recital 11 (11) The placing on the market within the Union of traditional foods from third countries should be facilitated, where the history of safe food use in a third country has been demonstrated. Those foods should have been consumed in a third country for at least 25 years as a part of the customary diet within a
Amendment 27 #
Proposal for a regulation Recital 11 (11) The placing on the market within the Union of traditional foods from third countries should be
Amendment 28 #
Proposal for a regulation Recital 12 (12) It should be clarified that foods from third countries which are regarded as novel foods in the Union should only be considered as traditional foods from third countries when they are derived from primary production as defined in Article 3 of Regulation (EC) No 178/2002, regardless of whether or not they are processed or unprocessed foods.
Amendment 29 #
Proposal for a regulation Recital 12 Amendment 30 #
Proposal for a regulation Recital 16 (16) The determination of whether a food was used for human consumption to a significant degree within the Union before 15 May 1997 should be based on information submitted by food business operators and, where appropriate, supported by other information available in
Amendment 31 #
Proposal for a regulation Recital 17 (17) Novel foods should be authorised and used only if they fulfil the criteria laid down in this Regulation. Novel foods should be safe and their use should not mislead the consumer, thus requiring the use of clear and precise labelling. Therefore, where a novel food is intended to replace another food, it should not differ from that food in a way that would be nutritionally, and as regards health, less advantageous for the consumer. The safety of novel foods shall be assessed on the basis of the precautionary principle as defined in Article 7 of Regulation (EC) No 178/2002.
Amendment 32 #
Proposal for a regulation Recital 17 (17) Novel foods should be authorised and used only if they fulfil the criteria laid down in this Regulation. Novel foods should be safe and their use should not mislead the consumer. Therefore, where a novel food is intended to replace another food, it should not differ from that food in a way that would be nutritionally less advantageous for the consumer. When a novel food comes from third countries, the scope of its use and its composition should not pose a safety risk to human health when exposed to a different climatic conditions and environment.
Amendment 33 #
Proposal for a regulation Recital 19 (19) It is appropriate to authorise a novel food by updating the Union list subject to the criteria and the procedures laid down in this Regulation. A procedure that is efficient, time-limited and transparent
Amendment 34 #
Proposal for a regulation Recital 19 (19) It is appropriate to authorise a novel
Amendment 35 #
Proposal for a regulation Recital 21 Amendment 36 #
Proposal for a regulation Recital 21 (21) As regards the possible use of nanomaterials for food use, EFSA considered in its opinion of 6 April 2011 on Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain21 that limited information is available in relation to aspects of nanotoxicokinetics and toxicology of engineered nanomaterials and that existing toxicity testing methods may need methodological modifications. In order to better assess the safety of nanomaterials for food use, bearing in mind the precautionary principle, the Commission is developing test methods which take into account specific characteristics of engineered nanomaterials. __________________ 21 «Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain», EFSA Journal 2011; 9(5):2140.
Amendment 37 #
Proposal for a regulation Recital 23 Amendment 38 #
Proposal for a regulation Recital 24 (24) Novel foods are subject to the general labelling requirements laid down in Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers and other relevant labelling requirements in Union food law. In certain cases it may be necessary to provide for additional labelling information, in particular regarding the description of the food, its source or its conditions of use to ensure that consumers are sufficiently informed of the nature of the novel food. Therefore, when a novel food is included in the Union list or in the list of traditional foods from third countries, specific conditions of use or labelling obligations may be imposed, which might, inter alia, relate to any specific characteristic or food property, such as composition, nutritional value or nutritional effects and intended use of the food, or to ethical considerations or implications for the health of specific groups of the population. It is appropriate to lay down in this Regulation specific labelling obligations in respect of food ingredients present in the form of engineered nanomaterials which fall within the scope of this Regulation.
Amendment 39 #
Proposal for a regulation Recital 24 (24) Novel foods are subject to the general
Amendment 40 #
Proposal for a regulation Recital 24 (24) Novel foods are subject to the general labelling requirements laid down in Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers and other relevant labelling requirements in Union food law. In certain cases it may be necessary to provide for additional labelling information, in particular regarding the description of the food, its
Amendment 41 #
Proposal for a regulation Recital 24 (24) Novel foods are subject to the general labelling requirements laid down in Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers and other relevant labelling requirements in Union food law. I
Amendment 42 #
Proposal for a regulation Recital 26 (26) The Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and should take all measures necessary to ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive and should help to ensure a level playing field.
Amendment 43 #
Proposal for a regulation Recital 26 (26) The Member States should lay down a common system of rules on penalties applicable to infringements of the provisions of this Regulation and should take all measures necessary to ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.
Amendment 44 #
Proposal for a regulation Recital 26 a (new) (26a) In the event of an infringement of this Regulation, Member States should be able to share information they possess in the interest of protecting public health.
Amendment 45 #
Proposal for a regulation Article 1 – paragraph 1 1. This Regulation lays down rules for the
Amendment 46 #
Proposal for a regulation Article 1 – paragraph 2 – point c (c) food falling within the scope of Council Directive XXX/XX/EU on [on the placing on the market of food from animal clones]. Until Council Directive XXX/XX/EU on [on the placing on the market of food from animal clones] enters into force, foods derived from cloned animals and their descendants shall not be authorised and/or placed on the Union list of novel foods authorised to be placed on the market within the Union.
Amendment 47 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point ii Amendment 48 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iii – indent 2 Amendment 49 #
Proposal for a regulation Article 2 – paragraph 2 – point b (b) ‘traditional food from a third country’ means novel food, other than the novel food as referred to in point (a)(i) to (iii), which is derived from primary production and processed derivatives as defined in Regulation 178/2002, with a history of safe food use and significant consumption in a third country;
Amendment 50 #
Proposal for a regulation Article 2 – paragraph 2 – point b (b) ‘traditional food from a third country’ means novel food, other than the novel food as referred to in point (a)(i) to (iii), which is derived from primary production, with a history of safe food use in at least two third countr
Amendment 51 #
Proposal for a regulation Article 2 – paragraph 2 – point c (c) ‘history of safe food use in a third country’ means that the safety of the food in question has been confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a
Amendment 52 #
Proposal for a regulation Article 2 – paragraph 2 – point c (c) ‘history of safe food use in a third country’ means that the safety of the food in question has been confirmed with compositional data and from experience of continued use and significant consumption for at least 25 years in the customary diet of a large part of the population of a third country, prior to a notification referred to in Article 13;
Amendment 53 #
Proposal for a regulation Article 2 – paragraph 2 – point c (c) ‘history of safe food use in a third country’ means that the safety of the food in question has been confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a large part of the population of a third country, prior to a notification referred to in Article 13, and with the information referred to in Article 19(1)(a);
Amendment 54 #
Proposal for a regulation Article 2 – paragraph 2 – point d (d) ‘the applicant’ means the Member State, the third country, or the interested party, who may represent several interested parties, or an SME, who has submitted an application in accordance with Article 9 or 15 or a notification in accordance with Article 13 to the Commission;
Amendment 55 #
Proposal for a regulation Article 2 – paragraph 2 – point e a (new) (ea) ‘cloned animals’ means animals produced by means of a method of asexual, artificial reproduction with the aim of producing a genetically identical or nearly identical copy of an individual animal;
Amendment 56 #
Proposal for a regulation Article 2 – paragraph 2 – point e b (new) (eb) ‘descendants of cloned animals’ means animals produced by means of sexual reproduction, in cases in which at least one of the progenitors is a cloned animal;
Amendment 57 #
Proposal for a regulation Article 2 – paragraph 2 a (new) 2a. The items referred to in Article 1(2) of this Regulation shall not be covered by the definition of ‘novel foods’.
Amendment 58 #
Proposal for a regulation Article 4 – paragraph 3 – subparagraph 1 The Commission may, by means of implementing acts, specify the procedural steps of the consultation process provided for in paragraph 2. This provision notwithstanding, existing national arrangements governing the consultation process may remain in force in the Member States if they are not fundamentally at odds with the requirements laid down by the Commission.
Amendment 59 #
Proposal for a regulation Article 5 – paragraph 1 1. The Commission shall establish, publish and update a Union list of novel foods authorised to be placed on the market within the Union in accordance with Articles 6, 7 and 8 (‘the Union list’).
Amendment 60 #
Proposal for a regulation Article 5 – paragraph 1 1. The Commission shall establish and update a Union list of novel foods, which shall include a list of novel food from third countries, authorised to be placed on the market within the Union in accordance with Articles 6, 7 and 8 (‘the Union list’).
Amendment 61 #
Proposal for a regulation Article 5 – paragraph 1 a (new) 1a. The Union list shall be made public.
Amendment 62 #
Proposal for a regulation Article 6 – paragraph 1 – point a (a) it
Amendment 63 #
Proposal for a regulation Article 6 – paragraph 1 – point a (a) it does not, in the light of the Union’s precautionary principle and on the basis of
Amendment 64 #
Proposal for a regulation Article 6 – paragraph 1 – point a (a) it does not, on the basis of the scientific evidence available, pose a safety risk to animal and human health;
Amendment 65 #
Proposal for a regulation Article 6 – paragraph 1 – point c (c) where it is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer or would have an adverse effect on his health.
Amendment 66 #
Proposal for a regulation Article 6 – paragraph 1 – point c a (new) (ca) where relevant, no significant risk for animal health and welfare or for the environment has been established.
Amendment 67 #
Proposal for a regulation Article 6 – paragraph 1 – point c a (new) (ca) where it is possible to ensure the traceability of the materials used in its manufacture.
Amendment 68 #
Proposal for a regulation Article 8 – paragraph 1 a (new) 1a. The European Union shall strive to enhance the influence of its food safety legislation on the international standards established and recognised by the Codex Alimentarius.
Amendment 69 #
Proposal for a regulation Article 8 – paragraph 2 – point c (c) adding, removing or changing the conditions, specifications, mandatory labelling requirements or restrictions associated with the inclusion of a novel food on the Union list.
Amendment 70 #
Proposal for a regulation Article 8 – paragraph 3 – point b (b) the conditions under which the novel food may be used, in order to avoid, in particular, possible adverse effects on particular groups of the population, considering in particular the appearance of new allergies, the exceeding of maximum intake levels and risks in case of excessive consumption;
Amendment 71 #
Proposal for a regulation Article 8 – paragraph 3 – point c (c) additional specific labelling requirements to inform the final consumer of any specific characteristic or food property and ensure its traceability, such as the composition, provenance, nutritional value or nutritional effects and intended use of the food, which renders a novel food no longer equivalent to an existing food or of implications for the health of specific groups of the population;
Amendment 72 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point d (d)
Amendment 73 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point d (d)
Amendment 74 #
Proposal for a regulation Article 9 – paragraph 2 (2) The Commission
Amendment 75 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission
Amendment 76 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission
Amendment 77 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission
Amendment 78 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 2 – point b (b) whether the composition of the novel food and the conditions of its use are consistent with the Union’s precautionary principle and thus do not pose a safety risk to human health in the Union.
Amendment 79 #
Proposal for a regulation Article 10 – paragraph 3 – subparagraph 3 Amendment 80 #
Proposal for a regulation Article 10 – paragraph 4 4. Where the additional information referred to in paragraph 3 is not sent to EFSA within the additional period referred to in that paragraph,
Amendment 81 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 1 – point a (a) the conditions provided for in Article 6
Amendment 82 #
Proposal for a regulation Article 11 – paragraph 2 Amendment 83 #
Proposal for a regulation Article 13 – paragraph 2 – point c (c) its country of origin and the countries of origin of the materials used in its manufacture;
Amendment 84 #
Proposal for a regulation Article 13 – paragraph 2 – point d (d) documented data demonstrating the history of safe food use in at least two third countr
Amendment 85 #
Proposal for a regulation Article 13 – paragraph 2 – point d (d) documented data demonstrating the history of safe food use and significant consumption in a third country;
Amendment 86 #
Proposal for a regulation Article 13 – paragraph 2 – point d (d) documented data demonstrating the history of safe food use in a third country, in accordance with Article 19(1)(a);
Amendment 87 #
Proposal for a regulation Article 13 – paragraph 2 – point e (e)
Amendment 88 #
Proposal for a regulation Article 14 – paragraph 2 (2) Within
Amendment 89 #
Proposal for a regulation Article 14 – paragraph 4 4. Where no reasoned safety objections are made 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 without delay the list of traditional food from third countries included in the Union list.
Amendment 90 #
Proposal for a regulation Article 16 – paragraph 1 (1) EFSA shall adopt its opinion within
Amendment 91 #
Proposal for a regulation Article 16 – paragraph 2 – point b (b) whether the composition of the novel food and the conditions of its use
Amendment 92 #
Proposal for a regulation Article 16 – paragraph 4 – subparagraph 1 In duly justified cases, where EFSA requests additional information from the applicant, the period of
Amendment 93 #
Proposal for a regulation Article 16 – paragraph 4 – subparagraph 3 Where the Commission does not object within eight working days of being informed by EFSA, the period of
Amendment 94 #
Proposal for a regulation Article 16 – paragraph 5 5. Where the additional information referred to in paragraph 4 is not sent to EFSA within the additional period referred to in that paragraph,
Amendment 95 #
Proposal for a regulation Article 16 – paragraph 6 – subparagraph 2 In such cases, EFSA shall give its opinion within the period of
Amendment 96 #
Proposal for a regulation Article 17 – paragraph 1 – subparagraph 1 – point a (a) the conditions provided for in Article 6
Amendment 97 #
Proposal for a regulation Article 20 – paragraph 1 – subparagraph 1 Where the Commission or EFSA requests additional information from an applicant on matters concerning risk management, it shall determine
Amendment 98 #
Proposal for a regulation Article 20 – paragraph 2 2. Where the additional information referred to in paragraph 1 is not
Amendment 99 #
Proposal for a regulation Article 22 – paragraph 1 source: 539.697
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Amendment 100 #
Proposal for a regulation Recital 28 (28) The implementing powers relating to the
Amendment 101 #
Proposal for a regulation Recital 28 a (new) (28a) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules 1 a lays down general rules for the performance of official controls to verify compliance with food law. Therefore, the Member States are to carry out official controls in accordance with Regulation (EC) No 882/2004, in order to enforce compliance with the present Regulation. __________________ 1a OJ L 165, 30.4.2004, p. 1. Corrected version (OJ L 191, 28.5.2004, p. 1). Regulation as last amended by Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).
Amendment 102 #
Proposal for a regulation Article 1 – paragraph 1 1. This Regulation lays down rules for the placing of novel foods on the market within the Union in order to ensure
Amendment 103 #
Proposal for a regulation Article 1 – paragraph 1 1. This Regulation lays down rules for the placing of novel foods on the market within the Union in order to ensure
Amendment 104 #
Proposal for a regulation Article 1 – paragraph 1 1. This Regulation lays down rules for the placing of novel foods on the market within the Union in order to ensure a high level of protection of human health and consumers' interests and the effective functioning of the internal market, whil
Amendment 105 #
Proposal for a regulation Article 1 – paragraph 1 1. This Regulation lays down rules for the placing of novel foods on the market within the Union in order to ensure the effective functioning of the internal market while providing a high level of protection of human health and well-being, consumer interests and food quality.
Amendment 106 #
Proposal for a regulation Article 1 – paragraph 1 1. This Regulation lays down rules for the placing of novel foods on the market within the Union in order to ensure the effective functioning of the internal market while providing a high level of protection of human health and consumer interests
Amendment 107 #
Proposal for a regulation Article 1 – paragraph 1 1. This Regulation lays down rules for the placing of novel foods on the market within the Union in order to ensure the effective functioning of the internal market while providing a high level of protection of human health, the environment and consumer interests.
Amendment 108 #
Proposal for a regulation Article 1 – paragraph 2 – point a (a) genetically modified foods and their derivatives falling within the scope of Regulation (EC) No 1829/2003;
Amendment 109 #
Proposal for a regulation Article 1 – paragraph 2 – point c Amendment 110 #
Proposal for a regulation Article 1 – paragraph 2 – point c (c) food falling within the scope of Council Directive XXX/XX/EU on [on the placing on the market of food from animal clones]. Until Council Directive XXX/XX/EU on [on the placing on the market of food from animal clones] enters into force, foods derived from cloned animals and their descendants shall not be authorised and/or placed on the Union list of novel foods authorised to be placed on the market within the Union.
Amendment 111 #
Proposal for a regulation Article 1 – paragraph 2 – point c (c) food falling within the scope of Council Directive XXX/XX/EU on [on the placing on the market of food from animal clones]. Until the date of application of that Directive, no food from cloned animals and/or their descendants shall be placed on the market.
Amendment 112 #
Proposal for a regulation Article 1 – paragraph 2 a (new) 2a. The purpose of this Regulation is to provide a high level of protection of consumers' interests, and of animal welfare and the environment, while ensuring the effective functioning of the internal market.
Amendment 113 #
Proposal for a regulation Article 1 – paragraph 2 a (new) 2a. Food derived from cloned animals shall not be placed on the Union list of novel foods or be placed on the market.
Amendment 114 #
Proposal for a regulation Article 2 – paragraph 2 – point a – introductory part (a) ‘novel food’ means all food that was not used for human consumption
Amendment 115 #
Proposal for a regulation Article 2 – paragraph 2 – point a – introductory part (a) ‘novel food’ means all food that was not used for human consumption to a significant degree within the Union before 15 May 1997 irrespective of the date of accession of the various Member States to the Union and
Amendment 116 #
Proposal for a regulation Article 2 – paragraph 2 – point a – introductory part (a) " novel food " means all food that was not used for human consumption to a significant degree within the Union before 15 May 1997 irrespective of the date of
Amendment 117 #
Proposal for a regulation Article 2 – paragraph 2 – point a – introductory part (a) ‘novel food’ means all food that was not used for human consumption to a significant degree, interpreted as available in supermarkets, general food outlets or pharmacies, within the Union before 15 May 1997 irrespective of the date of accession of the various Member States to the Union and includes in particular:
Amendment 118 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i a (new) (ia) foods and food ingredients with a new or intentionally modified primary molecular structure;
Amendment 119 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i b (new) (ib) foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae;
Amendment 120 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i c (new) (ic) foods and food ingredients to which a production process not currently used has been applied, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances;
Amendment 121 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point -i (new) (-i) food with a new or intentionally modified molecular structure;
Amendment 122 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point -i a (new) (-ia) food containing, consisting of or produced from micro-organisms, fungi, algae and other materials of biological or mineral origin;
Amendment 123 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point -i b (new) Amendment 124 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point -i c (new) (-ic) food containing, consisting of or produced from animals or parts of animals, with the exception of animals that have been reared using traditional rearing methods and have a proven history of safe food use on the Union market;
Amendment 125 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i (i) food
Amendment 126 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i (i) food
Amendment 127 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i (i) food to which a new production process not used for food production within the Union before 15 May 1997 is applied, where that production process gives rise to
Amendment 128 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i (i) food to which a new production process not used for food production within the Union before 15 May 1997 is applied, where that production process gives rise to significant changes in the composition or structure of the food which affect its nutritional value, the way it is metabolised or the level of undesirable substances, determined on the basis of full risk assessment;
Amendment 129 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i (i) food to which a new production process not used for food production within the Union before 15 May 1997 is applied, where that production process gives rise to significant changes in the composition or structure of the food which affect its nutritional value, the way it is metabolised
Amendment 130 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i a (new) (ia) - food with a new or intentionally modified primary molecular structure;
Amendment 131 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i b (new) (ib) - food containing, consisting of, or produced from microorganisms, fungi or algae;
Amendment 132 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i c (new) (ic) food containing, consisting of, or produced from plants, or their parts, except for plants obtained by traditional propagating or breeding practices and having a history of safe food use within the Union, where those practices do not give rise to significant changes in the composition or structure of the food affecting their nutritional value, metabolism or level of undesirable substances;
Amendment 133 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i d (new) (id) food containing, consisting of, or produced from insects or their parts;
Amendment 134 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point ii Amendment 135 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point ii Amendment 136 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iii – indent 1 – a
Amendment 137 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iii – indent 2 Amendment 138 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iv a (new) (iva) food ingredients as botanical sources used or intended to be used for medical purposes falling with the scope of Directive 2001/83/EC;
Amendment 139 #
Proposal for a regulation Article 2 – paragraph 2 – point b (b) ‘traditional food from a third country’ means novel food, other than the novel food as referred to in point (a)(i) to
Amendment 140 #
Proposal for a regulation Article 2 – paragraph 2 – point c (c) ‘history of safe food use in a third country’ means that the safety of the food in question has been confirmed with compositional data and from experience of continued use and significant consumption for at least 25 years in the
Amendment 141 #
Proposal for a regulation Article 2 – paragraph 2 – point c (c) "history of safe food use in a third country" means that the safety of the food in question has been confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a
Amendment 142 #
Proposal for a regulation Article 2 – paragraph 2 – point e a (new) (ea) "compositional data" means detailed sets of information on the nutritionally important components of food and its chemical compositions which have to remain stable under different climatic and environment conditions in order to confirm the safety of foods, especially those coming from third countries.
Amendment 143 #
Proposal for a regulation Article 2 – paragraph 2 – point e a (new) (ea) "cloned animals" means animals produced by means of a method of asexual, artificial reproduction with the aim of producing a genetically identical or nearly identical copy of an individual animal;
Amendment 144 #
Proposal for a regulation Article 2 – paragraph 2 – point e b (new) (eb) "descendants of cloned animals" means animals produced by means of sexual reproduction, in cases in which at least one of the progenitors is a cloned animal;
Amendment 145 #
Proposal for a regulation Article 2 – paragraph 2 – subparagraph 2 (new) The list of foods and food ingredients shall be kept open in order to keep pace with scientific progress and new products development. If new categories are included, these shall be well defined, justified from a safety perspective and assessed on impact.
Amendment 146 #
Proposal for a regulation Article 3 Amendment 147 #
Proposal for a regulation Article 3 – title Amendment 148 #
Proposal for a regulation Article 3 – paragraph 1 In order to ensure the uniform implementation of this Regulation, the Commission may decide, by means of
Amendment 149 #
Proposal for a regulation Article 3 – paragraph 2 Those
Amendment 150 #
Proposal for a regulation Article 4 – paragraph 1 1. Food business operators shall verify whether or not the status of the food which they intend to place on the market within the Union falls within the scope of this Regulation.
Amendment 151 #
Proposal for a regulation Article 4 – paragraph 1 Amendment 152 #
Proposal for a regulation Article 4 – paragraph 1 – subparagraph 1 (new) Food business operators cannot apply for novel food status and a health claim at the same time in order to avoid overlapping assessments. The novel food product shall be considered safe before EFSA evaluates a health claim.
Amendment 153 #
Proposal for a regulation Article 4 – paragraph 2 2. Food business operators shall consult a Member State where they are unsure whether or not a food which they intend to place on the market within the Union falls within the scope of this Regulation. In that case, food business operators shall provide the necessary information to the Member State on request to enable it to determine
Amendment 154 #
Proposal for a regulation Article 4 – paragraph 2 2. Food business operators shall consult a Member State where they are unsure whether or not a food which they intend to place on the market within the Union falls within the scope of this Regulation.
Amendment 155 #
Proposal for a regulation Article 4 – paragraph 2 2. Food business operators shall in any event consult a Member State
Amendment 156 #
Proposal for a regulation Article 4 – paragraph 2 Amendment 157 #
Proposal for a regulation Article 4 – paragraph 2 a (new) 2a. Where necessary, agri-food business operators may consult other competent authorities and the Commission which shall communicate the result of the consultation to all Member States.
Amendment 158 #
Proposal for a regulation Article 4 – paragraph 3 – subparagraph 1 The Commission may, by means of
Amendment 159 #
Proposal for a regulation Article 4 – paragraph 3 – subparagraph 1 The Commission may, by means of
Amendment 160 #
Proposal for a regulation Article 4 – paragraph 3 – subparagraph 2 Amendment 161 #
Proposal for a regulation Article 4 – paragraph 3 – subparagraph 2 Those
Amendment 162 #
Proposal for a regulation Article 4 a (new) Article 4a Informing the consumer Member States shall be required to inform and reassure consumers that new husbandry or production techniques pose no danger to humans or animals.
Amendment 163 #
Proposal for a regulation Article 5 – paragraph 1 1.
Amendment 164 #
Proposal for a regulation Article 5 – paragraph 1 1. The
Amendment 165 #
Proposal for a regulation Article 5 – paragraph 1 1. The Commission shall establish and update a Union list of novel foods authorised, which shall include a list of traditional food from third countries, to be placed on the market within the Union in accordance with Articles 6, 7 and 8 (
Amendment 166 #
Proposal for a regulation Article 5 – paragraph 1 a (new) 1a. The Union list shall be made public.
Amendment 167 #
Proposal for a regulation Article 5 – paragraph 2 2. Only novel foods authorised and included in the Union list or in the list of traditional foods from third countries may be placed on the market within the Union as such and used in or on foods under the conditions of use specified therein.
Amendment 168 #
Proposal for a regulation Article 5 – paragraph 2 a (new) 2a. The Commission shall make the Union list available to the public on its website.
Amendment 169 #
Proposal for a regulation Article 5 – paragraph 2 a (new) 2 a. The Union list of novel foods should be publicly available from ...*. The Union list should be published both on the Commission's internet site, and in the Official Journal of the European Union. __________________ * 24 months following the date of entry into force of this Regulation.
Amendment 170 #
Proposal for a regulation Article 5 – paragraph 2 b (new) 2b. The Commission shall also make a list of rejected applications publicly available, in order to serve as reference for future applications.
Amendment 171 #
Proposal for a regulation Article 6 – paragraph 1 – point a (a) it does not, on the basis of the independent peer-reviewed scientific evidence available, pose a safety risk to
Amendment 172 #
Proposal for a regulation Article 6 – paragraph 1 – point a (a) it does not, on the basis of the scientific evidence available, pose a safety risk to human health, under normal consumption conditions and under different climatic and environmental ones;
Amendment 173 #
Proposal for a regulation Article 6 – paragraph 1 – point a (a) it does not, on the basis of the scientific evidence available, pose a safety risk to human health and where applicable the environment;
Amendment 174 #
Proposal for a regulation Article 6 – paragraph 1 – point a a (new) (aa) it is a healthy food that is free of pesticides, GMOs, hormones and antibiotics that may pose a risk to health or the environment;
Amendment 175 #
Proposal for a regulation Article 6 – paragraph 1 – point b (b) it is correctly labelled so that it's use does not mislead the consumer;
Amendment 176 #
Proposal for a regulation Article 6 – paragraph 1 – point b (b) its use does not mislead the consumer, even to a material degree;
Amendment 177 #
Proposal for a regulation Article 6 – paragraph 1 – point c (c) where it is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer or have a negative impact on his or her health.
Amendment 178 #
Proposal for a regulation Article 6 – paragraph 1 – point c a (new) (ca) where it is produced in a Member State, it must not have an impact on the environment; the opinion of the European Environment Agency concerning the extent to which the production process and normal consumption have a harmful impact on the environment must always be taken into account in the assessment.
Amendment 179 #
Proposal for a regulation Article 6 – paragraph 1 – point c a (new) (ca) where relevant, no significant risk for animal health and welfare or for the environment has been established.
Amendment 180 #
Proposal for a regulation Article 6 – paragraph 1 – point c a (new) (ca) it does not contain nanomaterials and has not been produced using nanotechnology processes.
Amendment 181 #
Proposal for a regulation Article 6 – paragraph 1 – point c a (new) (ca) In the event of doubt, due, for example, to insufficient scientific certainty or lack of data, the precautionary principle shall be applied and the food in question shall not be included in the Union list.
Amendment 182 #
Proposal for a regulation Article 7 – paragraph 1 Amendment 183 #
Proposal for a regulation Article 7 – paragraph 1 No
Amendment 184 #
Proposal for a regulation Article 7 – paragraph 2 Amendment 185 #
Proposal for a regulation Article 7 – paragraph 2 Th
Amendment 186 #
Proposal for a regulation Article 8 – paragraph 1 – introductory part 1. The Commission shall authorise a novel food and update the Union list in accordance with the rules laid down in
Amendment 187 #
Proposal for a regulation Article 8 – paragraph 1 – point a Amendment 188 #
Proposal for a regulation Article 8 – paragraph 1 – point b Amendment 189 #
Proposal for a regulation Article 8 – paragraph 2 – point c (c) adding, removing or changing the
Amendment 190 #
Proposal for a regulation Article 8 – paragraph 2 – point c (c) adding, removing or changing the
Amendment 191 #
Proposal for a regulation Article 8 – paragraph 3 – introductory part 3. The entry for a novel food in the Union list provided for in paragraph 2 shall include
Amendment 192 #
Proposal for a regulation Article 8 – paragraph 3 – introductory part 3. The entry for a novel food in the Union list provided for in paragraph 2 shall include
Amendment 193 #
Proposal for a regulation Article 8 – paragraph 3 – point a (a) a specification of the novel food and technological process;
Amendment 194 #
Proposal for a regulation Article 8 – paragraph 3 – point a a (new) (aa) the date of entry of the novel food in the Union list;
Amendment 195 #
Proposal for a regulation Article 8 – paragraph 3 – point a b (new) (ab) the name and address of the applicant;
Amendment 196 #
Proposal for a regulation Article 8 – paragraph 3 – point b (b) the conditions under which the novel food may be used, in order to avoid, in particular, possible adverse effects on particular groups of the population, taking into account the emergence of new allergies in particular, the exceeding of maximum intake levels and risks in case of excessive consumption;
Amendment 197 #
Proposal for a regulation Article 8 – paragraph 3 – point b (b) where relevant, the conditions under which the novel food may be used, in order to avoid, in particular, possible adverse effects on particular groups of the population, the exceeding of maximum intake levels and risks in case of excessive consumption;
Amendment 198 #
Proposal for a regulation Article 8 – paragraph 3 – point c (c) additional specific labelling requirements to inform the final consumer of any specific characteristic or food property, such as the composition, type of production, nutritional value or nutritional effects and intended use of the food, which renders a novel food no longer equivalent to an existing food or of implications for the
Amendment 199 #
Proposal for a regulation Article 8 – paragraph 3 – point c (c) additional specific labelling requirements to inform the final consumer of any specific characteristic or food property, such as the composition, nutritional value or nutritional effects
Amendment 200 #
Proposal for a regulation Article 8 – paragraph 3 – point c (c) where relevant, additional specific labelling requirements to inform the final consumer of any specific characteristic or food property, such as the composition, nutritional value or nutritional effects and intended use of the food, which renders a novel food no longer equivalent to an existing food or of implications for the health of specific groups of the population;
Amendment 201 #
Proposal for a regulation Article 8 – paragraph 3 – point c (c) additional specific labelling requirements to inform the final consumer of any specific characteristic or food property, such as the composition, nutritional value or nutritional effects and intended use of the food, which renders a novel food no longer equivalent to an existing food or of implications for the health of specific groups of the population; if a novel food consists of, or contains ingredients in the form of engineered nanomaterials, this shall be clearly indicated in the list of ingredients, and the names of such ingredients shall be followed by the word 'nano' in brackets;
Amendment 202 #
Proposal for a regulation Article 8 – paragraph 3 – point d (d) where relevant, a post-market monitoring requirement in accordance with Article 23.
Amendment 203 #
Proposal for a regulation Article 8 – paragraph 3 – point d a (new) (da) a reference to the source country/country of origin.
Amendment 204 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 1 The
Amendment 205 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 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 8 shall start either on the Commission's initiative or following
Amendment 206 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 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 8 shall start either on the Commission's initiative or following an application to the Commission by an applicant. The Commission shall forward the application to Member States and make it available to the public on its website.
Amendment 207 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 1 The procedure for authorising the placing
Amendment 208 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point -a (new) -a) the name and address of the applicant;
Amendment 209 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point b (b) the
Amendment 210 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point b a (new) (ba) the production method;
Amendment 211 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point b a (new) (b a) Production process;
Amendment 212 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point c (c) independent, peer-reviewed, publically available scientific evidence demonstrating that the novel food does not pose a safety risk to human health or the environment;
Amendment 213 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point c (c) conclusive scientific evidence produced by independent bodies demonstrating that the novel food does not pose a safety risk to human health or the environment;
Amendment 214 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point c (c) scientific evidence demonstrating that the novel food does not pose a safety risk to human health, and where relevant, no safety risk for animal health and welfare or for the environment;
Amendment 215 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point c (c) scientific evidence demonstrating that the novel food does not pose a safety risk to human health and where applicable the environment;
Amendment 216 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point c a (new) (ca) an analysis, supported by appropriate information and data, showing that the characteristics of the food are not different from those of its conventional counterpart, having regard to the accepted limits of natural variations for such characteristics;
Amendment 217 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point d (d) where app
Amendment 218 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point d a (new) (da) particulars concerning the physical and chemical properties of the novel food or the novel food ingredient.
Amendment 219 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission
Amendment 220 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission
Amendment 221 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission
Amendment 222 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission
Amendment 223 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission
Amendment 224 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission
Amendment 225 #
Proposal for a regulation Article 9 – paragraph 3 3. The
Amendment 226 #
Proposal for a regulation Article 9 – paragraph 3 3. 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 8 shall end with the adoption of
Amendment 227 #
Proposal for a regulation Article 9 – paragraph 4 – subparagraph 2 Amendment 228 #
Proposal for a regulation Article 9 – paragraph 4 – subparagraph 2 Amendment 229 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 1 Amendment 230 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 1 Where the Commission requests an opinion from EFSA, it shall forward the valid application to EFSA. EFSA shall adopt its opinion within
Amendment 231 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 2 – introductory part In assessing the safety of novel foods, EFSA shall, where appropriate and in accordance with the precautionary principle, consider the following:
Amendment 232 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 2 – point b (b) whether the composition of the novel food and the conditions of its use do not pose a safety risk to human health, animal health and welfare, or the environment in the Union.
Amendment 233 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 2 – point b (b) whether the composition of the novel food and the conditions of its use do not pose a safety risk to human health in the
Amendment 234 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 2 – point b (b) whether the composition of the novel food and the conditions of its use do not pose a safety risk to human health in the Union and where applicable to the environment.
Amendment 235 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 2 – point b a (new) (ba) whether the composition of the novel food and the conditions of its use do not pose a risk to animal health and welfare and/or the environment.
Amendment 236 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 2 – point b b (new) (bb) whether cumulative and synergistic effects might arise, and whether particular groups of the population could be adversely affected.
Amendment 237 #
Proposal for a regulation Article 10 – paragraph 3 – subparagraph 3 Amendment 238 #
Proposal for a regulation Article 10 – paragraph 4 4. Where the additional information referred to in paragraph 3 is not sent to EFSA within the additional period referred
Amendment 239 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 1 – introductory part Amendment 240 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 1 – introductory part Within nine months from the date of publication of EFSA's opinion, the Commission shall
Amendment 241 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 1 – point c Amendment 242 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 2 Amendment 243 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 2 That
Amendment 244 #
Proposal for a regulation Article 11 – paragraph 2 Amendment 245 #
Proposal for a regulation Article 12 – title Amendment 246 #
Proposal for a regulation Article 12 – paragraph 1 – introductory part By …24 at the latest, the Commission shall adopt
Amendment 247 #
Proposal for a regulation Article 12 – paragraph 1 – point a (a) the
Amendment 248 #
Proposal for a regulation Article 12 – paragraph 1 – point c Amendment 249 #
Proposal for a regulation Article 12 – paragraph 2 Those
Amendment 250 #
Proposal for a regulation Article 13 – paragraph 1 An applicant, who intends to place on the market within the Union a traditional food from a third country,
Amendment 251 #
Proposal for a regulation Article 13 – paragraph 2 – point -a (new) -a) the name and address of the applicant;
Amendment 252 #
Proposal for a regulation Article 13 – paragraph 2 – point a (a) the name and a description of the traditional food; the potential for allergenicity of the novel food and metabolism/toxicokinetic studies on the novel food ingredient;
Amendment 253 #
Proposal for a regulation Article 13 – paragraph 2 – point b a (new) (ba) the production method;
Amendment 254 #
Proposal for a regulation Article 13 – paragraph 2 – point e (e) where app
Amendment 255 #
Proposal for a regulation Article 13 – paragraph 2 – point e (e)
Amendment 256 #
Proposal for a regulation Article 13 – paragraph 2 – point e (e) where applicable, the conditions of use and specific labelling requirements, including legitimate factors such as ethical concerns, which do not mislead the consumer.
Amendment 257 #
Proposal for a regulation Article 13 – paragraph 2 – point e a (new) (ea) the method of preparation and specifications of a novel food ingredient.
Amendment 258 #
Proposal for a regulation Article 14 – paragraph 1 1. The Commission shall forward the valid notification provided for in Article 13 with
Amendment 259 #
Proposal for a regulation Article 14 – paragraph 1 1. The Commission shall forward the valid notification provided for in Article 13 without delay to the Member States and to EFSA and shall make it available to the public on its website.
Amendment 260 #
Proposal for a regulation Article 14 – paragraph 2 2. Within four months from the date on which the valid notification is forwarded by the Commission in accordance with paragraph 1, a Member State or EFSA may submit to the Commission reasoned safety objections,
Amendment 261 #
Proposal for a regulation Article 14 – paragraph 2 2. Within four months from the date on which the valid notification is forwarded by the Commission in accordance with paragraph 1, a Member State or EFSA may submit to the Commission reasoned
Amendment 262 #
Proposal for a regulation Article 14 – paragraph 3 3. The Commission shall inform the Member States, EFSA and the applicant of the outcome of the procedure referred to in paragraph 2. Even if no reasoned safety objections are presented, traditional foods from third countries shall automatically go through a full risk assessment by EFSA at the beginning of the procedure.
Amendment 263 #
Proposal for a regulation Article 14 – paragraph 4 4. Where no reasoned safety objections are made in accordance with paragraph 2 within the time-limit laid down in that paragraph, the Commission shall authorise, after a convincing full risk assessment by EFSA, the placing on the market within the Union of the traditional food concerned and update without delay the Union list.
Amendment 264 #
Proposal for a regulation Article 14 – paragraph 4 4. Where no reasoned
Amendment 265 #
Proposal for a regulation Article 14 – paragraph 4 4. Where no reasoned safety objections are made 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
Amendment 266 #
Proposal for a regulation Article 14 – paragraph 5 – subparagraph 1 Where reasoned
Amendment 267 #
Proposal for a regulation Article 16 – paragraph 2 – point a (a) whether the history of safe food use in a third country, assessed on the basis of scientific guidelines and criteria that shall be clarified, is substantiated by reliable data submitted by the applicant in accordance with Articles 13 and 15;
Amendment 268 #
Proposal for a regulation Article 16 – paragraph 2 – point b (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 and where applicable the environment.
Amendment 269 #
Proposal for a regulation Article 16 – paragraph 2 – point b a (new) (ba) whether the novel food meant to replace another food does not have different properties that result in nutritional disadvantages for the consumer;
Amendment 270 #
Proposal for a regulation Article 16 – paragraph 5 5. Where the additional information referred to in paragraph 4 is not sent to EFSA within the additional period referred to in that paragraph, it shall
Amendment 271 #
Proposal for a regulation Article 17 – paragraph 1 – subparagraph 1 – introductory part Amendment 272 #
Proposal for a regulation Article 17 – paragraph 1 – subparagraph 1 – introductory part Within three months of the date of publication of EFSA's opinion, the Commission shall
Amendment 273 #
Proposal for a regulation Article 17 – paragraph 1 – subparagraph 2 Amendment 274 #
Proposal for a regulation Article 18 For removing a traditional food from a third country from the Union list or for adding, removing or changing
Amendment 275 #
Proposal for a regulation Article 18 Amendment 276 #
Proposal for a regulation Article 19 – paragraph 1 – point a (a) the
Amendment 277 #
Proposal for a regulation Article 19 – paragraph 1 – point d Amendment 278 #
Proposal for a regulation Article 19 – paragraph 2 Those
Amendment 279 #
Proposal for a regulation Article 20 – paragraph 1 – subparagraph 1 Where the Commission or EFSA requests additional information from an applicant on matters concerning risk management, it shall determine
Amendment 280 #
Proposal for a regulation Article 20 – paragraph 2 2. Where the additional information referred to in paragraph 1 is not
Amendment 282 #
Proposal for a regulation Article 22 – paragraph 1 Amendment 283 #
Proposal for a regulation Article 22 – paragraph 1 1. Applicants may request confidential treatment of certain information submitted under this Regulation where disclosure of such information may significantly harm their competitive position. However, applicants may not request confidential treatment of certain information submitted under this Regulation where this might result in unfair competition on the Union market.
Amendment 284 #
Proposal for a regulation Article 22 – paragraph 4 – subparagraph 2 – point d (d)
Amendment 285 #
Proposal for a regulation Article 22 – paragraph 5 5. The Commission, the Member States and EFSA shall take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation in accordance with paragraph 4, except for information which is required to be made public in order to protect human health, the environment and animal health.
Amendment 286 #
Proposal for a regulation Article 22 – paragraph 8 – subparagraph 2 Those
Amendment 287 #
Proposal for a regulation Article 23 – paragraph 2 Amendment 288 #
Proposal for a regulation Article 23 – paragraph 2 – introductory part Amendment 289 #
Proposal for a regulation Article 23 – paragraph 2 – point a (a) any new scientific evidence or technical
Amendment 290 #
Proposal for a regulation Article 23 a (new) Article 23 a Requirements concerning new information The food business operators shall forthwith inform the Commission of: a) any new scientific or technical information which might influence the evaluation of the safety in use of the novel food; b) any prohibition or restriction imposed by any third country in which the novel food is placed on the market.
Amendment 291 #
Proposal for a regulation Article 26 Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be harmonised, effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by …26 at the latest and shall notify it without delay of any subsequent amendment affecting them. __________________ 26 Publications Office: please insert date: 24 months after the date of entry into force of this Regulation.
Amendment 292 #
Proposal for a regulation Article 26 a (new) Article 26a Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 4(1), 9 (3), 11(1), and 17 (1) shall be conferred on the Commission for a period of 7 years after entry into force of this Regulation. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 7-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Articles 4(1), 9 (3), 11(1), and 17 (1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or on a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Articles 4(1), 9 (3), 11(1), and 17 (1) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council.
Amendment 293 #
Proposal for a regulation Article 27 – title Amendment 294 #
Proposal for a regulation Article 27 – paragraph 1 Amendment 295 #
Proposal for a regulation Article 27 – paragraph 1 a (new) Amendment 296 #
Proposal for a regulation Article 27 – paragraph 2 – subparagraph 1 Amendment 297 #
Proposal for a regulation Article 27 – paragraph 2 – subparagraph 2 Amendment 298 #
Proposal for a regulation Article 27 – paragraph 2 – subparagraph 2 Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result
Amendment 299 #
Proposal for a regulation Article 27 – paragraph 3 – subparagraph 1 Amendment 300 #
Proposal for a regulation Article 27 – paragraph 3 – subparagraph 2 Amendment 301 #
Proposal for a regulation Article 27 – paragraph 3 – subparagraph 2 Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result
Amendment 302 #
Proposal for a regulation Article 27 a (new) Article 27a Review No later than 3 years after the date of application of this Regulation and in the light of experience gained, the Commission shall forward to Parliament and Council a report on its implementation and, in particular, of Articles 3 and 8, accompanied, where appropriate, by any proposals. The report shall be made public.
Amendment 303 #
Proposal for a regulation Article 29 – paragraph 3 Amendment 304 #
Proposal for a regulation Article 29 – paragraph 3 3. The Commission may, by means of
Amendment 305 #
Proposal for a regulation Article 29 – paragraph 3 a (new) 3a. Until Council Directive XXX/XX/EU on [on the placing on the market of food from animal clones] enters into force, foods derived from cloned animals and their descendants shall not be authorised and/or placed on the Union list of novel foods authorised to be placed on the market within the Union.
Amendment 306 #
Proposal for a regulation Article 30 – paragraph 1 This Regulation shall not enter into force until Council Directive XXX/XX/EU [on the placing on the market of food from animal clones] is in force. This condition being satisfied, this Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Amendment 307 #
Proposal for a regulation Annex (new) Union List of authorised novel foods and list of traditional foods from third countries
Amendment 31 #
Proposal for a regulation Recital 1 (1) The free movement of safe and wholesome food is an essential aspect
Amendment 32 #
Proposal for a regulation Recital 1 (1) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, as well as benefitting their social and economic interests. Differences between national laws concerning the safety assessment and authorisation of novel foods may hinder the free movement of such food, thereby creating unfair conditions of competition, as well as among agri-food business operators and SMEs.
Amendment 33 #
Proposal for a regulation Recital 1 a (new) (1a) The right to produce and consume healthy food that is free of pesticides, GMOs, hormones and antibiotics that may pose a risk to human and animal health or to the environment is part of the fight for food sovereignty and a fundamental human right.
Amendment 34 #
Proposal for a regulation Recital 2 (2) A high level of protection of human health and of consumers’ interests, of the environment and animal welfare, and the effective functioning of the internal market should be assured in the pursuit of Union food policies, whilst ensuring transparency.
Amendment 35 #
Proposal for a regulation Recital 2 (2) A high level of protection of human health and of consumers’ interests
Amendment 36 #
Proposal for a regulation Recital 2 (2) A high level of protection of human health, based on the precautionary principle, and of consumers’ interests and the effective functioning of the internal market should be assured in the pursuit of Union food policies, whilst ensuring transparency.
Amendment 37 #
Proposal for a regulation Recital 2 (2) A high level of protection of human health and of consumers’ interests and of the environment and the effective functioning of the internal market should be assured in the pursuit of Union food policies, whilst ensuring transparency.
Amendment 38 #
Proposal for a regulation Recital 2 (2) A high level of protection of human health and of consumers’ interests and the effective functioning of the internal market should be assured in the pursuit of Union food policies, whilst ensuring transparency. A high level of protection and improvement of the quality of the environment is among the objectives of the Union as established in the Treaty on the European Union.
Amendment 39 #
Proposal for a regulation Recital 2 (2) A high level of protection of human health and of consumers’ interests and the effective functioning of the internal market should be assured in the pursuit of Union food policies, whilst ensuring transparency. Due attention should be given to the protection of the environment.
Amendment 40 #
Proposal for a regulation Recital 2 (2) A high level of protection of human health
Amendment 41 #
Proposal for a regulation Recital 2 a (new) (2a) Article 13 of the Treaty on the Functioning of the European Union provides that the Union and the Member States are to pay full regard to the welfare requirements of animals when formulating and implementing, inter alia, the Union's agriculture, fisheries and internal market policies. When implementing this Regulation, therefore, due attention should be given to the welfare of animals and implementation should be fully in line with all relevant provisions of Union law on animal welfare, including Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes and Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes.
Amendment 42 #
Proposal for a regulation Recital 5 Amendment 43 #
Proposal for a regulation Recital 5 a (new) (5a) This Regulation should apply to foods and food ingredients which fall under the following categories: foods and food ingredients with a new or intentionally modified primary molecular structure; foods and food ingredients consisting of or isolated from micro- organisms, fungi or algae; foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances. The list should be kept open in order to keep pace with scientific progress and new products development. If new categories are included, these should be well defined, justified from a safety perspective and assessed on impact.
Amendment 44 #
Proposal for a regulation Recital 6 (6) In order to ensure continuity with the rules laid down in Regulation (EC) No
Amendment 45 #
Proposal for a regulation Recital 6 (6) In order to ensure continuity with the rules laid down in Regulation (EC) No 258/97, the absence of a use for human consumption to a significant degree, interpreted as available in supermarkets, general food outlets or pharmacies, within the Union before the date of entry into force of that Regulation, namely 15 May 1997, should be maintained as a criterion for a food to be considered as a novel food. A use within the Union should also refer to a use in the Member States irrespective of the date of accession of the various Member States to the Union.
Amendment 46 #
Proposal for a regulation Recital 7 (7) Emerging technologies in food production processes
Amendment 47 #
Proposal for a regulation Recital 7 (7) Emerging technologies in food production processes may have an impact on food and thereby on food safety. Therefore,
Amendment 48 #
Proposal for a regulation Recital 7 (7) Emerging technologies in food production processes may have an impact on food and thereby on food safety. Therefore, it should also be clarified that a food should be considered as a novel food where a production process which was not previously used for food production in the Union is applied to that food
Amendment 49 #
Proposal for a regulation Recital 7 (7) Emerging technologies in food production processes may have an impact on food and thereby on food safety.
Amendment 50 #
Proposal for a regulation Recital 7 (7) Emerging technologies in food production processes may have an impact on food and thereby on food safety. Therefore, it should also be clarified that a food should be considered as a novel food where a production process which was not previously used for food production in the Union is applied to that food or when foods contain or consist of engineered nanomaterials, as defined in Article 2(2)(t)
Amendment 51 #
Proposal for a regulation Recital 7 (7) Emerging technologies in food production processes may have an impact on food and thereby on food safety and on the environment. Therefore, it should also be clarified that a food should be considered as a novel food where a production process which was not previously used for food production in the Union is applied to that food or when foods contain or consist of engineered nanomaterials, as defined in Article 2(2)(t) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council16 .
Amendment 52 #
Proposal for a regulation Recital 8 a (new) (8a) Foods with a new or intentionally modified primary molecular structure, foods consisting of, or isolated from, micro-organisms, fungi or algae, new strains of micro-organism with no history of safe use and concentrates of substances that naturally occur in plants should be considered as novel foods as defined in this Regulation.
Amendment 53 #
Proposal for a regulation Recital 9 (9) When there is a significant change in the production process of a substance that has been used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013,
Amendment 54 #
Proposal for a regulation Recital 9 (9) When there is a significant change in the production process of a substance that has been used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013,
Amendment 55 #
Proposal for a regulation Recital 9 (9) When there is a significant change in the production process of a substance that has been used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013, or a change in particle size of such a substance, for example through nanotechnology, it may have an impact on food and thereby on food safety. Therefore, that substance should be considered a novel food under this Regulation and should be re-evaluated first in accordance with this Regulation, after full risk assessment, and subsequently in accordance with the relevant specific legislation.
Amendment 56 #
Proposal for a regulation Recital 10 (10) If, prior to 15 May 1997, a food was used exclusively as, or in, a food supplement, as defined in point (a) of Article 2 of Directive 2002/46/EC, it should be allowed to be placed on the market within the Union after that date for the same use without being considered a novel food for the purposes of this Regulation. However, that use as, or in, a food supplement should not be taken into account for the assessment of whether the food was used for human consumption to a significant degree, interpreted as available in supermarkets, general food outlets or pharmacies, within the Union before 15 May 1997. Therefore, uses of the food concerned other than in, or as, a food supplement should be subject to this Regulation.
Amendment 57 #
Proposal for a regulation Recital 11 (11) T
Amendment 58 #
Proposal for a regulation Recital 11 (11) The placing on the market within the Union of traditional foods from third countries should be facilitated, where the history of safe food use in a third country has been demonstrated. Those foods should have been consumed in a third country for at least 25 years as a part of the
Amendment 59 #
Proposal for a regulation Recital 11 (11) The placing on the market within the Union of traditional foods from third countries should be facilitated, where the history of safe food use in a third country
Amendment 60 #
Proposal for a regulation Recital 11 (11) The placing on the market within the Union of traditional foods from third countries should be facilitated, where the history of safe food use in a third country has been demonstrated. Those foods should have been consumed in a third country for at least 25 years as a part of the customary diet within a
Amendment 61 #
Proposal for a regulation Recital 11 a (new) (11a) The determination of whether or not consumption of a food by the population of a third country is significant should be based on information supplied by food business operators and, where appropriate, backed up by other information available in the third country. When there is insufficient information on human consumption of a food, a simple and transparent procedure involving the Commission, the EFSA and food business operators should be established for collecting such information. Implementing powers should be conferred on the Commission to specify the procedural steps in such a consultation process.
Amendment 62 #
Proposal for a regulation Recital 12 (12) It should be clarified that foods from third countries which are regarded as novel foods in the Union should only be considered as traditional foods from third countries when they are derived from primary production as defined in Article 3 of Regulation (EC) No 178/2002, regardless of whether or not they are processed or unprocessed foods. Therefore,
Amendment 63 #
Proposal for a regulation Recital 13 (13) Food products produced from food ingredients that do not fall within the scope of this Regulation, in particular by changing the ingredients of the food, their composition or amount, should not be considered as novel foods. However, modifications of a food ingredient, such as selective extracts or the use of other parts of a plant, that have so far not been used for human consumption to a significant degree, interpreted as available in supermarkets, general food outlets or pharmacies, within the Union, should fall within the scope of this Regulation.
Amendment 64 #
Proposal for a regulation Recital 15 Amendment 65 #
Proposal for a regulation Recital 15 Amendment 66 #
Proposal for a regulation Recital 16 (16) The determination of whether a food was used for human consumption to a significant degree within the Union before
Amendment 67 #
Proposal for a regulation Recital 16 (16) The determination of whether a food was used for human consumption to a significant degree within the Union before 15 May 1997 should be based on information submitted by food business operators and, where appropriate, supported by other information available in the Member States. Food business operators should consult Member States
Amendment 68 #
Proposal for a regulation Recital 16 (
Amendment 69 #
Proposal for a regulation Recital 16 (16) The determination of whether a food was used for human consumption to a significant degree, interpreted as available in supermarkets, general food outlets or pharmacies, within the Union before 15 May 1997 should be based on information submitted by food business operators and, where appropriate, supported by other information available in the Member States. Food business operators should consult Member States if they are unsure of the status of the food they intend to place on the market. When there is no information or insufficient information available on human consumption before 15 May 1997, a simple and transparent procedure, involving the Commission, the Member States and food business operators, should be established for collecting such information. Implementing powers should be conferred on the Commission to specify the procedural steps of such consultation process.
Amendment 70 #
Proposal for a regulation Recital 16 a (new) (16a) Ethical and environmental aspects must be considered as part of the risk assessment during the authorisation procedure. Those aspects should be assessed by the European Group on Ethics in Science and New Technologies and the European Environment Agency respectively.
Amendment 71 #
Proposal for a regulation Recital 17 (17) Novel foods should be authorised and used only if they fulfil the criteria laid down in this Regulation. Novel foods should be safe and their use should not mislead the consumer, which implies clear and precise labelling. Therefore, where a novel food is intended to replace another food, it should not differ from that food in a way that would be nutritionally less advantageous for the consumer, or have negative effects on their health. The assessment of the safety of a novel food should be based on the precautionary principle as laid down in Article 7 of Regulation (EC) No 178/2002.
Amendment 72 #
Proposal for a regulation Recital 17 (17) Novel foods should be authorised and used only if they fulfil the criteria laid down in this Regulation. Novel foods should be safe and their use should not mislead the consumer. Product labelling requirements are therefore of the utmost importance, particularly if the novel food has been created using new rearing or farming methods, new materials or new production processes. Therefore, where a novel food is intended to replace another food, it should not differ from that food in a way that would be nutritionally less advantageous for the consumer.
Amendment 73 #
Proposal for a regulation Recital 17 (17) Novel foods should be authorised and used only if they fulfil the criteria laid down in this Regulation. Novel foods should be safe and their use should not mislead the consumer. Therefore consumers should be informed about the content of novel foods, the ingredients and the technologies used in the manufacture thereof. Similarly, where a novel food is intended to replace another food, it should not differ from that food in a way that would be nutritionally less advantageous for the consumer.
Amendment 74 #
Proposal for a regulation Recital 17 (17) Novel foods should be authorised and used only if they fulfil the criteria laid down in this Regulation. Novel foods should be safe and their use should not mislead the consumer. Therefore, where a novel food is intended to replace another food, it should not differ from that food in a way that would be nutritionally less advantageous or inferior quality for the consumer.
Amendment 75 #
Proposal for a regulation Recital 18 (18) Novel foods should not be placed on the market or used in food for human consumption unless they are included in a Union list of novel foods authorised to be placed on the market within the Union (‘the Union list’). Therefore, it is appropriate to establish
Amendment 76 #
Proposal for a regulation Recital 18 (18) Novel foods should not be placed on the market or used in food for human consumption unless they are included in a Union list of novel foods authorised to be placed on the market within the Union (‘the Union list’). Therefore, it is appropriate to establish
Amendment 77 #
Proposal for a regulation Recital 18 a (new) (18a) New technologies and innovations like biotechnology and nanotechnology in food production should be fostered as this could reduce the environmental impact of food production, enhance food security and bring benefits to consumers. Developments in food production should therefore always be judged according to the latest available scientific evidence in order to ensure sound scientific confirmation of European food safety.
Amendment 78 #
Proposal for a regulation Recital 19 (19) It is appropriate to authorise a novel food by updating the Union list subject to the criteria and the procedures laid down in this Regulation. A procedure that is efficient, time-limited and transparent should be put in place. As regards traditional foods from third countries having a history of safe use it is appropriate to provide for a faster and simplified procedure to update the Union list if no reasoned safety objections are expressed.
Amendment 79 #
Proposal for a regulation Recital 19 (19) It is appropriate to authorise a novel food by updating the Union list subject to the criteria and the procedures laid down in this Regulation. A procedure that is efficient, time-limited and transparent should be put in place. As regards traditional foods from third countries having a history of safe use it is appropriate to provide for a faster and simplified procedure to update the Union list if no reasoned safety objections are expressed.
Amendment 80 #
Proposal for a regulation Recital 19 (19) It is appropriate to authorise a novel food by updating the Union list subject to the criteria and the procedures laid down in this Regulation. A procedure that is efficient, time-limited and transparent should be put in place. As regards traditional foods from third countries having a history of safe use it is appropriate to provide for a faster and simplified procedure to update the Union list if no reasoned safety objections are expressed. As the updating of the Union list implies the application of criteria laid down in this Regulation, implementing powers should be conferred on the Commission in that respect. The Union list should be easily accessible and fully transparent.
Amendment 81 #
Proposal for a regulation Recital 20 (20) Criteria for the evaluation of the safety risks arising from novel foods should also be clearly defined and laid down. In order to ensure the harmonised scientific assessment of novel foods, such assessments should be carried out by the European Food Safety Authority (‘EFSA’). EFSA, whose assessments should be undertaken in a transparent manner, should set up a network with Member States and the Advisory Committee on Novel Foods and Processes (ACNFP). Any novel characteristic that may have an impact on health should be assessed on an individual basis.
Amendment 82 #
Proposal for a regulation Recital 21 Amendment 83 #
Proposal for a regulation Recital 21 (21) As regards the possible use of nanomaterials for food use, EFSA considered in its opinion of 6 April 201121 on Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain that
Amendment 84 #
Proposal for a regulation Recital 21 (21) As regards the possible use of nanomaterials for food use, EFSA considered in its opinion of 6 April 201121 on Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain that limited information is available in relation to aspects of nanotoxicokinetics and toxicology of engineered nanomaterials and that existing toxicity
Amendment 85 #
Proposal for a regulation Recital 21 a (new) (21a) Foods produced with engineered nanomaterials or nanomaterials for use in food subject to testing methods by the Commission should not be included in the Union list until they have been assessed and certified as food that is healthy and safe to eat.
Amendment 86 #
Proposal for a regulation Recital 21 a (new) (21a) The safety assessment and post market monitoring shall consider whether the compositional parameters of novel foods are subjected to significant changing due to lower hygienic controls and poor agriculture practices.
Amendment 87 #
Proposal for a regulation Recital 21 a (new) (21a) Food from cloned animals has been regulated under Regulation (EC) No 258/1997 and is due to be prohibited under the forthcoming regulation on the placing of the market of food from animal clones. In accordance with this forthcoming regulation, food from cloned animals should be excluded from the scope of this Novel Food Regulation and should not be placed on the market in the Union.
Amendment 88 #
Proposal for a regulation Recital 22 (22) When a novel food is authorised and included in the Union list, the Commission should have the power to introduce post- market monitoring requirements to monitor the use of the authorised novel food to ensure that the use is within safe limits as established in the safety assessment by EFSA. In any event, food business operators should inform the Commission of any relevant information regarding the food they have placed on the market.
Amendment 89 #
Proposal for a regulation Recital 23 Amendment 90 #
Proposal for a regulation Recital 23 (23) Under specific circumstances, in order to stimulate research and development within the agri-food industry, and thus innovation, it is appropriate to protect the investment made by innovators in gathering the information and data provided in support of an application for a novel food made in accordance with this Regulation. The newly developed scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the Union list should be protected. However, the protection of scientific data should not allow concealment of the content of novel foods or the technological process used. Those data and information should, for a limited period of time, not be used to the benefit of a subsequent applicant, without the agreement of the prior applicant. The protection of scientific data provided by one applicant should not prevent other applicants from seeking the inclusion in the Union list on the basis of their own scientific data or by referring to the protected data with the agreement of the prior applicant. However, the overall five year period of data protection which has been granted to the prior applicant
Amendment 91 #
Proposal for a regulation Recital 24 (24) Novel foods are subject to the general labelling requirements laid down in Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers and other relevant labelling requirements in Union food law. I
Amendment 92 #
Proposal for a regulation Recital 24 (24) Novel foods are subject to the general
Amendment 93 #
Proposal for a regulation Recital 24 (24) Novel foods are subject to the general labelling requirements laid down in Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers and other relevant labelling requirements in Union food law. In certain cases it may be necessary to provide for additional labelling information, in particular regarding the description of the food, its source or its conditions of use to ensure that consumers are sufficiently informed of the nature of the novel food. Materials that give rise to ethical concerns, as in current Regulation (EC) No 258/97, should also be indicated on the label in order to allow the consumers to make informed choices.
Amendment 94 #
Proposal for a regulation Recital 24 (24) Novel foods are subject to the general labelling requirements laid down in Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers and other relevant labelling requirements in Union food law. In certain cases it may be necessary to provide for additional labelling information, in particular regarding the description of the food, its source or its conditions of use to ensure that consumers are sufficiently informed of the nature of the novel food. Therefore, when a novel food is included in the Union list or in the list of traditional foods from third countries, specific conditions of use or labelling obligations may be imposed, which might, inter alia, relate to any specific characteristic or food property, such as composition, nutritional value or nutritional effects and intended use of the food, or to ethical considerations or implications for the health of specific groups of the population. It is appropriate to lay down in this Regulation specific labelling obligations in respect of food ingredients present in the form of engineered nanomaterials which fall within the scope of this Regulation.
Amendment 95 #
Proposal for a regulation Recital 25 a (new) (25a) This Regulation respects the fundamental rights and observes the principles recognised, in particular, by the Charter of Fundamental Rights of the European Union.
Amendment 96 #
Proposal for a regulation Recital 26 (26) The Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and should take all measures necessary to ensure that they are implemented. Those penalties sh
Amendment 97 #
Proposal for a regulation Recital 27 (27)
Amendment 98 #
Proposal for a regulation Recital 27 (27)
Amendment 99 #
Proposal for a regulation Recital 28 (28) The implementing powers relating to the d
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2014/10/20
ENVI
393 amendments...
Amendment 100 #
Proposal for a regulation Recital 4 (4) Foods which are intended to be used for technological purposes and genetically modified food
Amendment 101 #
Proposal for a regulation Recital 4 (4) Foods which are intended to be used for technological purposes and genetically modified food should not fall within the scope of this Regulation as they are already covered by other Union rules. Therefore, genetically modified food falling within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council10 and Directive 2001/18/EC, enzymes falling within the scope of Regulation (EC) No 1332/2008 of the European Parliament and of the Council11, food used solely as additives falling within the scope of Regulation (EC) No 1333/200812 of the European Parliament and of the Council, flavourings falling within the scope of Regulation (EC) No 1334/2008 of the European Parliament and of the Council13 and extraction solvents falling within the scope of Directive 2009/32/EC of the European Parliament and of the Council14 should be excluded from the scope of this Regulation. __________________ 10 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically
Amendment 102 #
Proposal for a regulation Recital 5 Amendment 103 #
Proposal for a regulation Recital 5 (5) The existing categories of novel food laid down in Article 1 of Regulation (EC) No 258/97 should be clarified and updated by
Amendment 104 #
Proposal for a regulation Recital 5 (5) The
Amendment 105 #
Proposal for a regulation Recital 5 (5) The
Amendment 106 #
Proposal for a regulation Recital 5 (5) The existing categories of novel food l
Amendment 107 #
Proposal for a regulation Recital 5 (5) The existing categories of novel food l
Amendment 108 #
Proposal for a regulation Recital 5 (5) The existing categories of novel food laid down in Article 1 of Regulation (EC) No 258/97 should be clarified and updated by replacing the existing categories with a reference to the general definition of food provided for in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council15. The categories to be defined should take into account the possibilities of technological innovation to ensure that such innovations, even disruptive innovations, follow the same authorisation procedures. __________________ 15 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
Amendment 109 #
Proposal for a regulation Recital 5 a (new) (5a) This Regulation should apply to foods and food ingredients which fall under the following categories: foods and food ingredients with a new or intentionally modified primary molecular structure; foods and food ingredients consisting of or isolated from micro- organisms, fungi or algae; foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances. The list should be kept open in order to keep pace with scientific progress and new products development. If new categories are included, these should be well defined, justified from a safety perspective and assessed on impact.
Amendment 110 #
Proposal for a regulation Recital 6 (6) In order to ensure continuity with the rules laid down in Regulation (EC) No 258/97, the absence of a use for human consumption to a significant degree, interpreted as available in supermarkets, general food outlets or pharmacies, within the Union before the date of entry into force of that Regulation, namely 15 May 1997, should be maintained as a criterion for a food to be considered as a novel food. A use within the Union should also refer to a use in the Member States irrespective of the date of accession of the various
Amendment 111 #
Proposal for a regulation Recital 7 (7) Emerging technologies in food production processes
Amendment 112 #
Proposal for a regulation Recital 7 (7) Emerging technologies in food production processes may have an impact on food and thereby on food safety. Therefore,
Amendment 113 #
Proposal for a regulation Recital 7 (7) Emerging technologies in food production processes may have an impact on food and thereby on food safety. Therefore, it should also be clarified that a food should be considered as a novel food where a production process which was not previously used for food production in the Union is applied to that food or when foods contain or consist of engineered nanomaterials
Amendment 114 #
Proposal for a regulation Recital 7 (7) Emerging technologies in food production processes may have an impact on food and thereby on food safety. Therefore, it should also be clarified that a food should be considered as a novel food where a production process which was not previously used for food production in the Union is applied to that food or when foods contain or consist of engineered nanomaterials
Amendment 115 #
Proposal for a regulation Recital 7 (7) Emerging technologies in food production processes may have an impact on food and thereby on food safety. Therefore, it should also be clarified that a food should be considered as a novel food where a production process which was not previously used for food production in the Union is applied to that food or when foods contain or consist of engineered nanomaterials
Amendment 116 #
Proposal for a regulation Recital 7 (7) Emerging technologies in food production processes may have an impact on food and thereby on food safety. Therefore, it should also be clarified that a food should be considered as a novel food where a production process which was not previously used for food production in the Union is applied to that food or when foods contain or consist of engineered nanomaterials, as defined in Article 2(2)(t) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council16, which account for not less than 10% of the food by weight or volume, as calculated by adding together the percentages present in the individual ingredients. __________________ 16 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of
Amendment 117 #
Proposal for a regulation Recital 7 a (new) (7a) According to the Commission Recommendation on the definition of nanomaterial (2011/696/EU) in specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50% may be replaced by a threshold between 1 and 50%. In view of the current uncertainties over safety, a lower nanoparticle number threshold, e.g. 10%, as proposed by the EFSA scientific Committee, should be considered for food related applications instead of the currently proposed (50%).
Amendment 118 #
Proposal for a regulation Recital 8 (8) Vitamins, minerals and other substances intended to be used in food supplements or to be added to food
Amendment 119 #
Proposal for a regulation Recital 8 a (new) (8a) Food with a new or intentionally modified primary molecular structure, food containing, consisting of, or produced from micro-organism, fungi or algae, food derived from tissue culture or cell culture, food containing, consisting of, isolated or produced from plants or animals or their parts, except for animals and plants obtained by traditional propagating or breeding practices, and having a history of safe food use within the Union market, should be considered as novel food as defined in this Regulation
Amendment 120 #
Proposal for a regulation Recital 8 a (new) (8a) Foods with a new or intentionally modified primary molecular structure, foods consisting of, or isolated from, micro-organisms, fungi or algae, new strains of micro-organism with no history of safe use and concentrates of substances that naturally occur in plants should be considered as novel foods as defined in this Regulation.
Amendment 121 #
Proposal for a regulation Recital 9 (9) When there is a significant change in the production process of a substance that has been used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013,
Amendment 122 #
Proposal for a regulation Recital 10 (10) If, prior to 15 May 1997, a food was used exclusively as, or in, a food supplement, as defined in point (a) of Article 2 of Directive 2002/46/EC, it should be allowed to be placed on the market within the Union after that date for the same use without being considered a novel food for the purposes of this Regulation. However, that use as, or in, a food supplement should not be taken into account for the assessment of whether the food was used for human consumption to a significant degree, interpreted as available in supermarkets, general food outlets or pharmacies, within the Union before 15 May 1997. Therefore, uses of the food concerned other than in, or as, a food supplement should be subject to this Regulation.
Amendment 123 #
Proposal for a regulation Recital 10 a (new) (10a) Food derived from cloned animals has been regulated under Regulation (EC) No 258/1997. It is crucial that no legal ambiguity emergences as regards the placing on the market of food from animal clones and/or their descendants. Until specific legislation on food derived from cloned animals and their descendants enters into force, this food should fall under the scope of this Regulation on the condition that, while placed on the market within the Union, it is appropriately labelled for the final consumer.
Amendment 124 #
Proposal for a regulation Recital 11 (11) The placing on the market within the Union of traditional foods from third countries should be
Amendment 125 #
Proposal for a regulation Recital 11 (11) The placing on the market within the Union of traditional foods from third countries, such as insects, should be facilitated, where the history of safe food use in a third country has been demonstrated. Those foods should have been consumed in a third country for at least 25 years as a part of the customary diet within a large part of the population of the country. The history of safe food use should not include non-food uses or uses not related to normal diets.
Amendment 126 #
Proposal for a regulation Recital 11 (11) The placing on the market within the Union of traditional foods from third countries should be facilitated, where the history of safe food use in a third country has been demonstrated. Those foods should have been consumed in a third country for at least
Amendment 127 #
Proposal for a regulation Recital 11 (11) The placing on the market within the Union of traditional foods from third countries should be facilitated, where the history of safe food use in a third country has been demonstrated. Those foods should have been consumed in a third country for at least 25 years as
Amendment 128 #
Proposal for a regulation Recital 11 (11) The placing on the market within the Union of traditional foods from third countries should be facilitated, where the history of safe food use in a third country has been demonstrated. Those foods should have been consumed in a third country for
Amendment 129 #
Proposal for a regulation Recital 11 a (new) (11a) The determination as to whether or not a food was consumed by the population of a third country to a significant degree should be based on information provided by food business operators and, where appropriate, supported by other information available in the third countries. Where there is insufficient information on human consumption of a food, a simple and transparent procedure involving the Commission, the EFSA and food business operators should be established to collect such information. Implementing powers should be conferred on the Commission to set out in detail the procedural stages of that consultation process.
Amendment 130 #
Proposal for a regulation Recital 12 (12) It should be clarified that foods from third countries which are regarded as novel foods in the Union should only be considered as traditional foods from third countries when they are derived from primary production as defined in Article 3 of Regulation (EC) No 178/2002
Amendment 131 #
Proposal for a regulation Recital 12 (12) It should be clarified that foods from third countries which are regarded as novel foods in the Union should only be considered as traditional foods from third countries when they are derived from primary production as defined in Article 3 of Regulation (EC) No 178/2002, regardless of whether or not they are processed or unprocessed foods. Therefore, where a new pro
Amendment 132 #
Proposal for a regulation Recital 12 (12) It should be clarified that foods from third countries which are regarded as novel foods in the Union should only be considered as traditional foods from third countries when they are derived from primary production as defined in Article 3 of Regulation (EC) No 178/2002, regardless of whether or not they are processed or unprocessed foods. Therefore, where a new production process has been applied to this food or where the food contains or consists of
Amendment 133 #
Proposal for a regulation Recital 12 (12) It should be clarified that foods from third countries which are regarded as novel foods in the Union should only be considered as traditional foods from third countries when they are derived from primary production as defined in Article 3 of Regulation (EC) No 178/2002, regardless of whether or not they are processed or unprocessed foods. Therefore, where a new production process has been applied to this food or where the food contains or consists of ‘engineered nanomaterials’
Amendment 134 #
Proposal for a regulation Recital 12 (12) It should be clarified that foods from third countries which are regarded as novel foods in the Union should only be considered as traditional foods from third countries when they are derived from primary production as defined in Article 3 of Regulation (EC) No 178/2002, regardless of whether or not they are processed or unprocessed foods. Therefore, where a new production process has been applied to this food or where the food contains or consists of ‘engineered nanomaterials’, as defined in Article 2(2)(t) of Regulation (EU) No 1169/2011, which account for not less than 10% of the food by weight or volume, as calculated by adding together the percentages present in the individual ingredients, the food should not be considered to be traditional.
Amendment 135 #
Proposal for a regulation Recital 13 (13) Food products produced from food ingredients that do not fall within the scope of this Regulation, in particular by changing the ingredients of the food, their composition or amount, should not be considered as novel foods. However, modifications of a food ingredient, such as selective extracts or the use of other parts
Amendment 136 #
Proposal for a regulation Recital 15 Amendment 137 #
Proposal for a regulation Recital 15 Amendment 138 #
Proposal for a regulation Recital 16 (16) The determination of whether a food was used for human consumption to a significant degree within the Union before 15 May 1997 should be based on information submitted by food business operators and, where appropriate, supported by other information available in the Member States. Food business operators should consult Member States if they are unsure of the status of the food they intend to place on the market. When there is no information or insufficient information available on human consumption before 15 May 1997, a simple and transparent procedure
Amendment 139 #
Proposal for a regulation Recital 16 (16) The determination of whether a food was used for human consumption to a significant degree within the Union before 15 May 1997 should be based on information submitted by food business operators and
Amendment 140 #
Proposal for a regulation Recital 16 Amendment 141 #
Proposal for a regulation Recital 16 (16) The determination of whether a food was used for human consumption to a
Amendment 142 #
Proposal for a regulation Recital 17 (17) Novel foods should be authorised and used only if they fulfil the criteria laid down in this Regulation. Novel foods should be safe and their use should not mislead the consumer. Therefore, where a novel food is intended to replace another food, it should not differ from that food in a way that would be
Amendment 143 #
Proposal for a regulation Recital 17 (17) Novel foods should be authorised and used only if they fulfil the criteria laid down in this Regulation. Novel foods should be safe, beneficial to consumers, and their use should not mislead the consumer. Therefore, where a novel food is intended to replace another food, it should not differ from that food in a way that would be nutritionally less advantageous for the consumer. The assessment of the safety of a novel food should be based on the precautionary principle as laid down in Article 7 of Regulation (EC) No 178/2002.
Amendment 144 #
Proposal for a regulation Recital 18 (18) Novel foods should not be placed on the market or used in food for human consumption unless they are included in a Union list of novel foods authorised to be placed on the market within the Union (‘the Union list’). Therefore, it is appropriate to establish
Amendment 145 #
Proposal for a regulation Recital 18 (18) Novel foods should not be placed on the market or used in food for human consumption unless they are included in a Union list of novel foods authorised to be placed on the market within the Union (‘the Union list’). Therefore, it is appropriate to establish
Amendment 146 #
Proposal for a regulation Recital 18 (18) Novel foods should not be placed on the market or used in food for human consumption unless they are included in a Union list of novel foods authorised to be placed on the market within the Union (‘the Union list’). Therefore, it is appropriate to establish, by means of an
Amendment 147 #
Proposal for a regulation Recital 18 (18) Novel foods should not be placed on the market or used in food for human consumption unless they are included in a Union list of novel foods authorised to be placed on the market within the Union (‘the Union list’). Therefore, it is appropriate to establish
Amendment 148 #
Proposal for a regulation Recital 18 (18) Novel foods should not be placed on the market or used in food for human consumption unless they are included in a Union list of novel foods authorised to be placed on the market within the Union (‘the Union list’). Therefore, it is appropriate to establish, by means of a
Amendment 149 #
Proposal for a regulation Recital 18 a (new) (18a) New technologies and innovations like biotechnology and nanotechnology in food production should be fostered as this could reduce the environmental impact of food production, enhance food security and bring benefits to consumers. Developments in food production should therefore always be judged according to the latest available scientific evidence in order to ensure sound scientific confirmation of European food safety.
Amendment 150 #
Proposal for a regulation Recital 19 (19) It is appropriate to authorise a novel food by updating the Union list subject to the criteria and the procedures laid down in this Regulation. A procedure that is efficient, time-limited and transparent should be put in place. As regards traditional foods from third countries having a history of safe use it is appropriate to provide for a faster and simplified procedure to update the Union list if no reasoned safety objections are expressed.
Amendment 151 #
Proposal for a regulation Recital 19 (19) It is appropriate to authorise a novel food by updating the Union list subject to the criteria and the procedures laid down in this Regulation. A
Amendment 152 #
Proposal for a regulation Recital 19 (19) It is appropriate to authorise a novel food by updating the Union list subject to the criteria and the procedures laid down in this Regulation. A procedure that is efficient, time-limited and transparent should be put in place. As regards traditional foods from third countries having a history of safe use it is appropriate to provide for a faster and simplified procedure to update the Union list if no reasoned safety objections are expressed.
Amendment 153 #
Proposal for a regulation Recital 19 (19) It is appropriate to authorise a novel food by updating the Union list subject to the criteria and the procedures laid down in this Regulation. A procedure that is efficient, time-limited and transparent should be put in place. As regards traditional foods from third countries having a history of safe use
Amendment 154 #
Proposal for a regulation Recital 19 (19) It is appropriate to authorise a novel food by updating the Union list subject to the criteria and the procedures laid down in this Regulation. A procedure that is efficient, time-limited and transparent should be put in place. As regards traditional foods from third countries having a history of safe use it is appropriate to provide for a faster and simplified procedure to update the Union list on a case-by-case basis if no reasoned safety objections are expressed. As the updating of the Union list implies the application of criteria laid down in this Regulation, implementing powers should be conferred on the Commission in that respect.
Amendment 155 #
Proposal for a regulation Recital 19 (19) It is appropriate to authorise a novel food by updating the Union list subject to the criteria and the procedures laid down in this Regulation. A procedure that is efficient, time-limited and transparent should be put in place. As regards traditional foods from third countries having a history of safe use it is appropriate to provide for a faster and simplified procedure to update the Union list if no reasoned safety objections are expressed.
Amendment 156 #
Proposal for a regulation Recital 20 (20) Criteria for the evaluation of the safety risks arising from novel foods should also be laid down. In order to ensure the harmonised scientific assessment of novel foods, such assessments should be carried out under a transparent and inclusive procedure by the European Food Safety Authority (‘EFSA’), in consultation with Member State health authorities, after stakeholder groups have been consulted.
Amendment 157 #
Proposal for a regulation Recital 20 (20) Criteria for the evaluation of the safety risks arising from novel foods should also be clearly defined and laid down. In order to ensure the harmonised scientific assessment of novel foods, such assessments should be carried out by the European Food Safety Authority (‘EFSA’). EFSA, whose assessments should be undertaken in a transparent manner, should set up a network with Member States and the Advisory Committee on Novel Foods and Processes (ACNFP). Any novel characteristic that may have an impact on health should be assessed on an individual basis.
Amendment 158 #
Proposal for a regulation Recital 21 Amendment 159 #
Proposal for a regulation Recital 21 (21) As regards the possible use of nanomaterials for food use, EFSA
Amendment 160 #
Proposal for a regulation Recital 21 (21) As regards the possible use of nanomaterials for food use, EFSA considered in its opinion of 6 April 201121 on Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain that limited information is available in relation to aspects of nanotoxicokinetics and toxicology of engineered nanomaterials and that existing toxicity testing methods may need methodological modifications. In order to better assess the safety of nanomaterials for food use, the Commission is developing test methods which take into account specific characteristics of engineered nanomaterials.
Amendment 161 #
Proposal for a regulation Recital 21 (21) As regards the possible use of nanomaterials for food use, EFSA considered in its opinion of 6 April 201121 on Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain that limited information is available in relation to aspects of nanotoxicokinetics and toxicology of engineered nanomaterials and that existing toxicity testing methods may need methodological modifications. In order to better assess the safety of nanomaterials for food use, the Commission is developing test methods which take into account specific characteristics of engineered nanomaterials.
Amendment 162 #
Proposal for a regulation Recital 21 a (new) (21a) In order to protect human health, the use of nanotechnologies in food production should be prohibited until appropriate nano-specific test methods have been approved for use and adequate safety assessments on the basis of these tests can be carried out.
Amendment 163 #
Proposal for a regulation Recital 21 b (new) (21b) Differing interpretations of the term ‘particle’ exist. It should therefore be clarified that foods containing soft nanomaterials, such as micelles or liposomes, are also covered by the definition of ‘novel food’.
Amendment 164 #
Proposal for a regulation Recital 21 c (new) (21c) When test methods are applied to nanomaterials, an explanation should be provided of their scientific appropriateness for nanomaterials, and, where applicable, of the technical adaptations/adjustments that have been made in order to respond to the specific characteristics of these materials.
Amendment 165 #
Proposal for a regulation Recital 21 d (new) (21d) Only nanomaterials entered in a list of approved substances should be present in food packaging, accompanied by a limit on migration into or onto the food products contained in such packaging.
Amendment 166 #
Proposal for a regulation Recital 22 (22) When a novel food is authorised and included in the Union list,
Amendment 167 #
Proposal for a regulation Recital 23 (23) Under specific circumstances, in order to stimulate research and development within the agri-food industry, and thus innovation, it is appropriate to protect the investment made by innovators in gathering the information and data provided in support of an application for a novel food made in accordance with this Regulation. The
Amendment 168 #
Proposal for a regulation Recital 23 (23) Under specific circumstances, in order to stimulate research and development within the agri-food industry, and thus innovation, it is appropriate to protect the investment made by innovators in gathering the information and data provided in support of an application for a novel food made in accordance with this Regulation. The newly developed scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the Union list should be protected. Those data and information should, for a limited period of time, not be used to the benefit of a subsequent applicant, without the agreement of the prior applicant. The protection of scientific data provided by one applicant should not prevent other applicants from seeking the inclusion in the Union list on the basis of their own scientific data or by referring to the protected data with the agreement of the prior applicant. However, the overall
Amendment 169 #
Proposal for a regulation Recital 23 a (new) (23a) While ensuring the confidentiality of the application, an indicative list of applications consisting of basic information should be made available by the Commission to interested parties. That list should prevent identical or duplicate applications from being submitted in succession and therefore reduce the administrative burden for both the potential applicants and the Union.
Amendment 170 #
Proposal for a regulation Recital 24 (24) Novel foods are subject to the general labelling requirements laid down in Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers and other relevant labelling requirements in Union food law. In certain cases it may be necessary to provide for additional labelling information, in particular regarding the description of the food, its source or its conditions of use to ensure that consumers are sufficiently informed of the nature of the novel food. Materials that give rise to ethical concerns, as in current Regulation (EC) No 258/97, should also be indicated on the label in order to allow the consumers to make informed choices.
Amendment 171 #
Proposal for a regulation Recital 24 a (new) (24a) Novel foods are subject to the requirements of Union law on materials and articles intended to come into contact with food, in particular Regulation (EC) No 1935/2004 of the European Parliament and of the Council1 a and the specific measures adopted pursuant thereto. __________________ 1a Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
Amendment 172 #
Proposal for a regulation Recital 24 b (new) (24b) In its 2010 second reading on the novel food dossier, the European Parliament, by a very large majority, asked for prohibiting the placing on the market of foods from cloned animals and their descendants. After the conciliation on novel foods failed in March 2011, the Commission committed to come forward with a specific proposal on cloned animals and their descendants, taking into account both the positions of Council and European Parliament. However, the proposals on cloning and clone food presented in December 2013 do not provide for any measures as regards descendants of cloned animals, not even with a view to inform the consumers. Moreover, it does not allow the European Parliament to exercise its rights as Co- legislator. It is therefore appropriate for the Commission to use the opportunity the appointment of the new College offers and to withdraw the 2013 proposals in order to come forward with new proposals, based on the ordinary legislative procedure, in order to take account of the demands by the Parliament.
Amendment 173 #
Proposal for a regulation Recital 25 a (new) (25a) In order to allow the Union list to be modified as new novel foods are authorised, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to update the Union list. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
Amendment 174 #
Proposal for a regulation Recital 27 Amendment 175 #
Proposal for a regulation Recital 27 (27) In order to ensure uniform conditions for the implementation of this Regulation with regard to updating the Union list concerning the adding of a traditional food from a third country where no reasoned safety objections have been expressed,
Amendment 176 #
Proposal for a regulation Recital 27 (27) In order to ensure uniform conditions for the implementation of this Regulation with regard to updating the Union list concerning the adding of a traditional food from a third country where no
Amendment 177 #
Proposal for a regulation Recital 27 (27)
Amendment 178 #
Proposal for a regulation Recital 27 (27)
Amendment 179 #
Proposal for a regulation Recital 28 Amendment 180 #
Proposal for a regulation Recital 28 (28) The implementing powers relating to the definition of ‘novel food’,
Amendment 181 #
Proposal for a regulation Recital 28 (28) The implementing powers relating to
Amendment 182 #
Proposal for a regulation Recital 28 (28) The implementing powers relating to
Amendment 183 #
Proposal for a regulation Recital 28 a (new) (28a) The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the authorisation of novel foods and of traditional foods from a third country, the updating of the Union list, and the consultation process for determination of a novel food status. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
Amendment 184 #
Proposal for a regulation Recital 28 b (new) (28b) In order to supplement or amend certain elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the definition of ‘novel food’, of the authorisation of a novel food and of a traditional food from a third country, of establishing and updating the Union list, and of adopting transitional measures. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
Amendment 185 #
Proposal for a regulation Recital 28 c (new) Amendment 186 #
Proposal for a regulation Article 1 – paragraph 1 1. This Regulation lays down rules for the placing of novel foods on the market within the Union in order to ensure the effective functioning of the internal market while providing a high level of protection of human health, animals and consumer interests.
Amendment 187 #
Proposal for a regulation Article 1 – paragraph 1 1. This Regulation lays down rules for the placing of novel foods on the market within the Union in order to ensure the effective functioning of the internal market while providing a high level of protection of human health, the environment and consumer interests.
Amendment 188 #
Proposal for a regulation Article 1 – paragraph 1 1. This Regulation lays down rules for the placing of novel foods on the market within the Union in order to ensure the effective functioning of the internal market while providing a high level of protection of human health and consumer interests and prohibiting the placing on the market of foods in which nanomaterials are used.
Amendment 189 #
Proposal for a regulation Article 1 – paragraph 1 a (new) 1a. The purpose of this Regulation is to provide a high level of protection of human health and of consumers’ interests, while ensuring the effective functioning of the internal market.
Amendment 190 #
Proposal for a regulation Article 1 – paragraph 1 b (new) 1b. The purpose of this Regulation is to provide a high level of protection of consumers’ interests, and of animal welfare and the environment, while ensuring the effective functioning of the internal market.
Amendment 191 #
Proposal for a regulation Article 1 – paragraph 2 – point a (a) genetically modified foods falling within the scope of Regulation (EC) No 1829/2003 and Directive 2001/18/EC;
Amendment 192 #
Proposal for a regulation Article 1 – paragraph 2 – point c Amendment 193 #
Proposal for a regulation Article 1 – paragraph 2 – point c (c) food
Amendment 194 #
Proposal for a regulation Article 1 – paragraph 2 – point c (c) food falling within the scope of Council Directive XXX/XX/EU on [on the placing on the market of food from animal clones]. Until Council Directive XXX/XX/EU on the placing on the market of food from animal clones enters into force, food derived from cloned animals and their descendants shall not be authorised and/or placed on the Union list of novel foods authorised to be placed on the market within the Union.
Amendment 195 #
Proposal for a regulation Article 1 – paragraph 2 – point c a (new) (ca) food which consists of engineered nanomaterials, including vitamins and minerals where these products consist of engineered nanomaterials.
Amendment 196 #
Proposal for a regulation Article 1 – paragraph 2 a (new) Amendment 197 #
Proposal for a regulation Article 2 – paragraph 2 – point a – introductory part (a)
Amendment 198 #
Proposal for a regulation Article 2 – paragraph 2 – point a – introductory part (a) ‘novel food’ means
Amendment 199 #
Proposal for a regulation Article 2 – paragraph 2 – point a – introductory part (a) ‘novel food’ means all food that was not used for human consumption to a significant degree within the Union before 15 May 1997 irrespective of the date of accession of the various Member States to the Union
Amendment 200 #
Proposal for a regulation Article 2 – paragraph 2 – point a – introductory part (a) ‘novel food’ means all food that was
Amendment 201 #
Proposal for a regulation Article 2 – paragraph 2 – point a – introductory part (a) ‘novel food’
Amendment 202 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point -i (new) (-i) food with a new or intentionally modified primary molecular structure;
Amendment 203 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point -i a (new) (-ia) food consisting of, isolated from or produced from animals or their parts, except for animals obtained by traditional breeding practices which have been used before 15 May 1997 and the food from those animals has a history of safe food use within the Union market;
Amendment 204 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point -i b (new) (-ib) food containing, consisting of, or produced from microorganisms, fungi or algae;
Amendment 205 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point -i c(new) (-ic) food containing, consisting of, isolated from or produced from plants, except for plants obtained by traditional propagating practices and having a history of safe food use within the Union market, where those practices do not give rise to significant changes in the composition or structure of the food affecting their nutritional value, metabolism or level of undesirable substances;
Amendment 206 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i (i) food to which a new production process not used for food production within the Union before 15 May 1997 is applied, where that production process gives rise to significant changes in the composition or structure of the food which affect its nutritional value, the way it is metabolised or the level of undesirable substances, or where that production process might give rise to ethical concerns;
Amendment 207 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i i) food to which a new production process not used for food production within the Union before 15 May 1997 is applied, where that production process gives rise to
Amendment 208 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i (i) food to which a new production process not used for food production within the Union before 15 May 1997 is applied, where that production process gives rise to significant changes, determined after full risk assessment, in the composition or structure of the food which affect its nutritional value, the way it is metabolised or the level of undesirable substances;
Amendment 209 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i a (new) (ia) foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having history of safe use;
Amendment 210 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i b (new) (ib) food derived from cloned animals and/or their descendants, subject to Article 29 a (new);
Amendment 211 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i c (new) (ic) foods and food ingredients with a new or intentionally modified primary molecular structure;
Amendment 212 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i d (new) (id) foods and food ingredients with a new or intentionally modified primary molecular structure;
Amendment 213 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i e (new) (ie) foods and food ingredients with a new or intentionally modified primary molecular structure;
Amendment 214 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i f (new) (if) food and food ingredients consisting of or isolated from microorganisms, fungi or algae;
Amendment 215 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i g (new) (ig) foods and food ingredients consisting of or isolated from microorganisms, fungi or algae;
Amendment 216 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i h (new) (ih) foods and food ingredients consisting of or isolated from microorganisms, fungi or algae;
Amendment 217 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i i (new) (ii) foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae;
Amendment 218 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i j (new) (ij) food derived from tissue culture or cell culture
Amendment 219 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i k (new) (ik) foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use;
Amendment 220 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i l (new) (il) foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances;
Amendment 221 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point i m (new) (im) foods and food ingredients consisting of or isolated from plants and animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use;
Amendment 222 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point ii Amendment 223 #
(ii) food
Amendment 224 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point ii (ii) food
Amendment 225 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point ii (ii) food
Amendment 226 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point ii (ii) food containing or consisting of
Amendment 227 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point ii ii) food containing or consisting of "engineered nanomaterials", as defined in Article 2(2)(t) of Regulation (EU) No 1169/2011, which account for not less than 10% of the food by weight or volume, as calculated by adding together the percentages present in the individual ingredients;
Amendment 228 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iii Amendment 229 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iii – indent 2 Amendment 230 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iii – indent 2 – such substances
Amendment 231 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iii – indent 2 – such substances
Amendment 232 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iii – indent 2 – such substances contain or consist of
Amendment 233 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iii – indent 2 a (new) - a new source or starting material has been used, for a single form or for mixtures of vitamins, minerals and other substances used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013;
Amendment 234 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iv a (new) (iva) food containing or consisting of insects and other invertebrates;
Amendment 235 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iv b (new) (ivb) food or food ingredients consisting of or isolated from plants derived from production processes that give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances;
Amendment 236 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iv c (new) (ivc) whole animals including insects, or food derived from animals, for which there is no history of safe use within the Union;
Amendment 237 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iv d (new) (ivd) food containing, consisting of, or obtained from cellular or tissue cultures;
Amendment 238 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iv e (new) ive) food containing or consisting of insects and other invertebrates;
Amendment 239 #
Proposal for a regulation Article 2 – paragraph 2 – point a – point iv f (new) (ivf) food containing, consisting of, or obtained from cellular or tissue cultures
Amendment 240 #
Proposal for a regulation Article 2 – paragraph 2 – point a a (new) (aa) The list of foods and food ingredients shall be kept open in order to keep pace with scientific progress and new products development. If new categories are included, these shall be well defined, justified from a safety perspective and assessed on impact;
Amendment 241 #
Proposal for a regulation Article 2 – paragraph 2 – point b (b) ‘traditional food from a third country’ means novel food, other than the novel food as referred to in point (a)(i) to (iii), which is derived from primary production, and is either unprocessed or has gone through a primary process without a secondary process that involves the combination of foods in a particular way to change the properties of the food, with a history of safe food use in a third country;
Amendment 242 #
Proposal for a regulation Article 2 – paragraph 2 – point b (b) ‘traditional food from a third country’ means novel food, other than the novel food as referred to in point (a)(-i)
Amendment 243 #
Proposal for a regulation Article 2 – paragraph 2 – point c (c) "history of safe food use in a third country" means that the safety of the food in question has been confirmed with compositional data and from experience of continued use
Amendment 244 #
Proposal for a regulation Article 2 – paragraph 2 – point c c) "history of safe food use in a third country" means that the safety of the food in question has been confirmed with compositional data and from experience of continued use for at least
Amendment 245 #
Proposal for a regulation Article 2 – paragraph 2 – point c (c) ‘history of safe food use in a third country’ means that the safety of the food in question has been confirmed with compositional data and from experience of continued use for at least 25 years
Amendment 246 #
Proposal for a regulation Article 2 – paragraph 2 – point e a (new) (ea) 'new production process' means a process not used for food production within the Union before 15 May 1997
Amendment 247 #
Proposal for a regulation Article 2 – paragraph 2 – point e b (new) (eb) 'Cloned animals' means animals produced by means of a method of asexual, artificial reproduction with the aim of producing a genetically identical or nearly identical copy of an individual animal
Amendment 248 #
Proposal for a regulation Article 2 – paragraph 2 – point e c (new) (ec) 'descendants of cloned animals' means animals produced by means of sexual reproduction, in cases in which at least one of the progenitors is a cloned animal
Amendment 249 #
Amendment 250 #
Proposal for a regulation Article 3 – title Amendment 251 #
Amendment 252 #
Proposal for a regulation Article 3 – title Amendment 253 #
Proposal for a regulation Article 3 – paragraph 1 In order to ensure th
Amendment 254 #
Proposal for a regulation Article 3 – paragraph 1 Amendment 255 #
Proposal for a regulation Article 3 – paragraph 1 Amendment 256 #
Proposal for a regulation Article 3 – paragraph 2 Amendment 257 #
Proposal for a regulation Article 3 – paragraph 2 Amendment 258 #
Proposal for a regulation Article 3 – paragraph 2 Those
Amendment 259 #
Proposal for a regulation Article 4 – paragraph 1 Amendment 260 #
Proposal for a regulation Article 4 – paragraph 1 – subparagraph 1 (new) Food business operators shall not apply for novel food status and a health claim at the same time in order to avoid overlapping assessments. Until EFSA evaluates a health claim, the novel food product shall be considered safe.
Amendment 261 #
Proposal for a regulation Article 4 – paragraph 2 2. Food business operators shall consult
Amendment 262 #
Proposal for a regulation Article 4 – paragraph 2 2. Food business operators shall consult a Member State where they are unsure whether or not a food which they intend to place on the market within the Union falls within the scope of this Regulation. In that case, food business operators shall provide
Amendment 263 #
Proposal for a regulation Article 4 – paragraph 2 2. Food business operators shall consult a Member State where they are unsure whether or not a food which they intend to place on the market within the Union falls within the scope of this Regulation.
Amendment 264 #
Proposal for a regulation Article 4 – paragraph 2 2. Food business operators shall consult a Member State where they are unsure whether or not a food which they intend to
Amendment 265 #
Proposal for a regulation Article 4 – paragraph 3 – subparagraph 1 The Commission may, by means of
Amendment 266 #
Proposal for a regulation Article 4 – paragraph 3 – subparagraph 1 The Commission may, by means of
Amendment 267 #
Proposal for a regulation Article 4 – paragraph 3 – subparagraph 1 The Commission may, by means of
Amendment 268 #
Proposal for a regulation Article 4 – paragraph 3 – subparagraph 2 Amendment 269 #
Proposal for a regulation Article 4 – paragraph 3 – subparagraph 2 Those
Amendment 270 #
Proposal for a regulation Article 4 – paragraph 3 – subparagraph 2 Those
Amendment 271 #
Proposal for a regulation Article 4 a (new) Article 4 a Implementing power concerning the definition of novel food in Article 2 (2) (a) In order to ensure the uniform implementation of this Regulation, the Commission shall decide on its own initiative or upon the request of a Member State and by means of implementing acts, whether or not a particular food falls within the definition of novel food, as laid down in Article 2 (2) (a).
Amendment 272 #
Proposal for a regulation Article 5 – paragraph 1 1. The
Amendment 273 #
Proposal for a regulation Article 5 – paragraph 1 1.
Amendment 274 #
1. The Commission shall establish and update a Union list of novel foods authorised to be placed on the market within the Union in accordance with Articles 6, 7 and 8 ("the Union list"). That list, together with the reasons for the relevant decisions, shall be freely available to the public for consultation.
Amendment 275 #
Proposal for a regulation Article 5 – paragraph 2 2. Only novel food
Amendment 276 #
Proposal for a regulation Article 5 – paragraph 2 a (new) 2a. The Union list shall be made available to the public 12 months after this Regulation enters into force. The Union list shall be published on the Commission website and in the Official Journal of the European Union.
Amendment 277 #
Proposal for a regulation Article 5 – paragraph 2 b (new) 2b. The Commission shall make the Union list available to the public on its website.
Amendment 278 #
Proposal for a regulation Article 5 – paragraph 2 c (new) 2c. The Commission shall also make a list of rejected applications publicly available, in order to serve as reference for future applications.
Amendment 279 #
Proposal for a regulation Article 6 – paragraph 1 – point a (a) it does not, on the basis of the scientific evidence available, pose a safety risk to human health, nor to animal welfare or the environment;
Amendment 280 #
Proposal for a regulation Article 6 – paragraph 1 – point a a) it does not, on the basis of
Amendment 281 #
Proposal for a regulation Article 6 – paragraph 1 – point a (a) it does not, on the basis of the scientific evidence available, pose a safety risk to
Amendment 282 #
Proposal for a regulation Article 6 – paragraph 1 – point b (b) its use does not mislead the consumer, but offers benefits to consumers;
Amendment 283 #
Proposal for a regulation Article 6 – paragraph 1 – point b (b) its
Amendment 284 #
Proposal for a regulation Article 6 – paragraph 1 – point c Amendment 285 #
Proposal for a regulation Article 6 – paragraph 1 – point c (c) where it is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer. In the case of diverging opinions among the scientific studies referred to in point (a), a conclusion shall be drawn taking into account the opinion of the EFSA.
Amendment 286 #
Proposal for a regulation Article 6 – paragraph 1 – point c c) where it is intended to replace another food, it
Amendment 287 #
Proposal for a regulation Article 6 – paragraph 1 a (new) In the event of doubt, due, for example, to insufficient scientific certainty or lack of data, the precautionary principle shall be applied and the food in question shall not be included in the Union list.
Amendment 288 #
Proposal for a regulation Article 6 – paragraph 1 b (new) Foods to which production processes have been applied that require specific risk assessment methods (for example, foods produced using nanotechnologies as referred to in Article 2 (2) (ii)) may not be included in the Union list until such specific methods have been approved by EFSA for use, and an adequate safety assessment on the basis of those methods has shown that the use of the respective foods is safe.
Amendment 289 #
Proposal for a regulation Article 7 – paragraph 1 No
Amendment 290 #
Proposal for a regulation Article 7 – paragraph 1 Amendment 291 #
Proposal for a regulation Article 7 – paragraph 1 No later than …23 the Commission shall, by means of a
Amendment 292 #
Proposal for a regulation Article 7 – paragraph 1 No later than
Amendment 293 #
Proposal for a regulation Article 7 – paragraph 1 No later than …23 the Commission shall, by means of a
Amendment 294 #
Proposal for a regulation Article 7 – paragraph 1 No later than …
Amendment 295 #
Proposal for a regulation Article 7 – paragraph 1 No later than …
Amendment 296 #
Proposal for a regulation Article 7 – paragraph 1 No later than …
Amendment 297 #
Proposal for a regulation Article 7 – paragraph 2 Amendment 298 #
Proposal for a regulation Article 7 – paragraph 2 That
Amendment 299 #
Proposal for a regulation Article 7 – paragraph 2 Th
Amendment 300 #
Proposal for a regulation Article 7 – paragraph 2 That
Amendment 301 #
Proposal for a regulation Article 8 – paragraph 1 – introductory part 1. The Commission shall authorise a novel food and update the Union public list in accordance with the rules laid down in:
Amendment 302 #
Proposal for a regulation Article 8 – paragraph 2 – introductory part 2. The authorisation of a novel food and updating of the Union public list provided for in paragraph 1 shall consist of one of the following:
Amendment 303 #
Proposal for a regulation Article 8 – paragraph 2 – point a a) adding a novel food to the Union public list;
Amendment 304 #
Proposal for a regulation Article 8 – paragraph 2 – point b b) removing a novel food from the Union public list;
Amendment 305 #
Proposal for a regulation Article 8 – paragraph 2 – point c (c) adding,
Amendment 306 #
Proposal for a regulation Article 8 – paragraph 2 – point c c) adding, removing or changing the conditions, specifications or restrictions associated with the inclusion of a novel food on the Union
Amendment 307 #
Proposal for a regulation Article 8 – paragraph 3 – introductory part 3. The entry for a novel food in the Union list provided for in paragraph 2 shall include
Amendment 308 #
Proposal for a regulation Article 8 – paragraph 3 – introductory part 3. The entry for a novel food in the Union list provided for in paragraph 2 shall include
Amendment 309 #
Proposal for a regulation Article 8 – paragraph 3 – introductory part 3. The entry for a novel food in the Union list provided for in paragraph 2 shall include
Amendment 310 #
Proposal for a regulation Article 8 – paragraph 3 – point a a (new) (aa) the date of entry of the novel food in the Union list
Amendment 311 #
Proposal for a regulation Article 8 – paragraph 3 – point a b (new) (ab) the name and address of the applicant;
Amendment 312 #
Proposal for a regulation Article 8 – paragraph 3 – point b Amendment 313 #
Proposal for a regulation Article 8 – paragraph 3 – point b (b) where relevant, the conditions under which the novel food may be used, in order to avoid, in particular, possible adverse effects on particular groups of the population, the exceeding of maximum intake levels and risks in case of excessive consumption;
Amendment 314 #
Proposal for a regulation Article 8 – paragraph 3 – point c (c) where relevant, additional specific labelling requirements to inform the final consumer of any specific characteristic or food property, such as the composition, nutritional value or nutritional effects and intended use of the food, which renders a novel food no longer equivalent to an existing food or of implications for the
Amendment 315 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 1 The
Amendment 316 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 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 8 shall start either on the Commission's initiative or following an application to the Commission by an
Amendment 317 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 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 8 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.
Amendment 318 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point a (a) the name and description of the novel food and an explanation of the intended use;
Amendment 319 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point a a (new) (aa) the name and address of the applicant;
Amendment 320 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point a b (new) (ab) the description of the methods used to produce the novel food;
Amendment 321 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point b b) the detailed chemical composition of the novel food;
Amendment 322 #
c) scientific evidence demonstrating that the novel food does not pose a safety risk to human health or the environment;
Amendment 323 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – point c (c) scientific evidence demonstrating that the novel food does not pose a safety risk to human health and where applicable to the environment;
Amendment 324 #
Proposal for a regulation Article 9 – paragraph 1 – subparagraph 2 – points d a to d i (new) (da) the adverse effects and health incidents already identified by the health authorities concerning this novel food, specifying the date, the number and type of people affected and their symptoms; (db) the allergenic potential, with particular regard to the molecular structure of the novel food; (dc) the target population of the novel food, specifying, in particular, whether it might be consumed by children; (dd) contraindications and restrictions, with reasons; (de) the current state of the category into which the novel food falls, specifying in particular the products used until now and their faults and advantages for the sector and for consumers; (df) the advantages of the novel food, particularly for consumers; (dg) where the novel food is an ingredient, the preparations in which it may be incorporated and its interactions with the other ingredients of these preparations; (dh) the possibility of obtaining this novel food through an ‘organic’ process; (di) unfavourable scientific data concerning the novel food, where such data exists.
Amendment 325 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission
Amendment 326 #
Proposal for a regulation Article 9 – paragraph 2 2.
Amendment 327 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission
Amendment 328 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission
Amendment 329 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission
Amendment 330 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission
Amendment 331 #
Proposal for a regulation Article 9 – paragraph 2 a (new) 2a. The Commission shall acknowledge receipt of the application to the applicant within 15 days of receiving the application. Within one month after reception of the application, the Commission shall verify the validity of the application. Where the application has not been considered as valid, the Commission shall inform the applicant thereof, specifying the reasons and stop the procedure.
Amendment 332 #
Proposal for a regulation Article 9 – paragraph 2 b (new) 2b. When test methods are applied to nanomaterials as referred to in Article 2 (2) (ii), an explanation shall be provided 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 these materials.
Amendment 333 #
Proposal for a regulation Article 9 – paragraph 3 3. 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 8 shall end with the adoption of a
Amendment 334 #
Proposal for a regulation Article 9 – paragraph 3 3. The procedure for authorising the
Amendment 335 #
Proposal for a regulation Article 9 – paragraph 3 3. 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 8 shall end with the adoption of
Amendment 336 #
Proposal for a regulation Article 9 – paragraph 3 3. 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 8 shall end with the adoption of an
Amendment 337 #
Proposal for a regulation Article 9 – paragraph 3 3. The
Amendment 338 #
Proposal for a regulation Article 9 – paragraph 4 – subparagraph 2 Amendment 339 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 1 Amendment 340 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 1 Where the Commission requests an opinion from EFSA, it shall forward the valid application to EFSA. EFSA shall adopt its opinion within
Amendment 341 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 2 – introductory part In assessing the safety of novel foods, EFSA shall
Amendment 342 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 2 – introductory part In assessing the safety of novel foods, EFSA shall
Amendment 343 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 2 – introductory part In assessing the safety of novel foods, EFSA shall, where appropriate and in accordance with the precautionary principle, consider the following:
Amendment 344 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 2 – point b (b) whether the composition of the novel food and the conditions of its use do not pose a safety risk to human health in the Union, taking account of vulnerable consumers or particular groups of consumers.
Amendment 345 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 2 – point b (b) whether the composition of the novel food and the conditions of its use do not pose a safety risk to human health in the Union and where applicable to the environment .
Amendment 346 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 2 – point b a (new) (ba) whether the composition of the novel food and the conditions of its use do not pose a risk to animal health and welfare and/or the environment;
Amendment 347 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 2 – point b b (new) (bb) whether the novel food concerned does not have properties resulting in nutritional disadvantages to the consumers compared to another food it is meant to replace;
Amendment 348 #
(bc) whether cumulative and synergistic effects could arise, and whether particular groups of the population could be adversely affected.
Amendment 349 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 2 – point b d (new) (bd) whether 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.
Amendment 350 #
Proposal for a regulation Article 10 – paragraph 4 4. Where the additional information referred to in paragraph 3 is not
Amendment 351 #
Proposal for a regulation Article 10 – paragraph 4 4. Where the additional information referred to in paragraph 3 is not sent to EFSA within the additional period referred to in that paragraph,
Amendment 352 #
Proposal for a regulation Article 10 – paragraph 5 – subparagraph 1 Where applicants submit additional information on their own initiative, they shall send it to the Commission, to the Member States and to EFSA.
Amendment 353 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 1 – introductory part Within
Amendment 354 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 1 – introductory part Within
Amendment 355 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 1 – introductory part Within
Amendment 356 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 1 – introductory part Within nine months from the date of publication of EFSA's opinion, the Commission shall
Amendment 357 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 1 – introductory part Amendment 358 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 1 – point c Amendment 359 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 2 Amendment 360 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 2 That
Amendment 361 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 2 That
Amendment 362 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 2 That
Amendment 363 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 2 That
Amendment 364 #
Proposal for a regulation Article 11 – paragraph 2 Amendment 365 #
Proposal for a regulation Article 11 – paragraph 2 Amendment 366 #
Proposal for a regulation Article 11 – paragraph 2 Amendment 367 #
Proposal for a regulation Article 11 – paragraph 2 2. Where the Commission has not requested an opinion from EFSA in accordance with Article 9(2), the
Amendment 368 #
Proposal for a regulation Article 11 – paragraph 2 2. Where the Commission has not requested an opinion from EFSA in accordance with Article 9(2), the
Amendment 369 #
Proposal for a regulation Article 12 – title Amendment 370 #
Proposal for a regulation Article 12 – paragraph 1 – introductory part By …24 at the latest, the Commission shall adopt
Amendment 371 #
Proposal for a regulation Article 12 – paragraph 1 – point a (a) the contents, drafting and presentation of the application referred to in Article 9(1), including a precise and exhaustive list of documents required for an application to be valid;
Amendment 372 #
Proposal for a regulation Article 12 – paragraph 1 – point a (a) the
Amendment 373 #
Proposal for a regulation Article 12 – paragraph 1 – point c Amendment 374 #
Proposal for a regulation Article 12 – paragraph 2 Those
Amendment 375 #
Proposal for a regulation Article 13 – paragraph 2 – point a (a) the name and a description of the traditional food and an explanation of the intended use;
Amendment 376 #
Proposal for a regulation Article 13 – paragraph 2 – point b b) its detailed chemical composition;
Amendment 377 #
Proposal for a regulation Article 13 – paragraph 2 – point b a (new) (ba) the name and address of the applicant;
Amendment 378 #
Proposal for a regulation Article 13 – paragraph 2 – point c (c) its country/countries of origin;
Amendment 379 #
Proposal for a regulation Article 13 – paragraph 2 – point d d) documented scientific data demonstrating the history of safe food use in a third country;
Amendment 380 #
Proposal for a regulation Article 13 – paragraph 2 – point d (d) documented data demonstrating the history of safe food use in a third country, as set out in the EFSA guidelines;
Amendment 381 #
Proposal for a regulation Article 13 – paragraph 2 – point e (e)
Amendment 382 #
Proposal for a regulation Article 13 – paragraph 2 – point e (e) where applicable, the conditions of use and specific labelling requirements, including legitimate factors such as ethical concerns, which do not mislead the consumer.
Amendment 383 #
Proposal for a regulation Article 13 – paragraph 2 – point e (e)
Amendment 384 #
Proposal for a regulation Article 13 – paragraph 2 – points e a and e b (new) (ea) the adverse effects and health incidents already identified by the health authorities concerning this traditional food, specifying the date, the number and type of people affected and the symptoms; (eb) the allergenic potential, with particular regard to the molecular structure of the traditional food and existing data;
Amendment 385 #
Proposal for a regulation Article 14 – paragraph 1 1. The Commission shall forward the valid notification provided for in Article 13 without delay to the Member States and to EFSA and shall make it available to the public on its website.
Amendment 386 #
Proposal for a regulation Article 14 – paragraph 2 2. Within four months from the date on which the valid notification is forwarded by the Commission in accordance with paragraph 1, a Member State or EFSA may submit to the Commission
Amendment 387 #
Proposal for a regulation Article 14 – paragraph 2 2. Within four months from the date on which the valid notification is forwarded by the Commission in accordance with paragraph 1, a Member State and/or EFSA may submit to the Commission reasoned
Amendment 388 #
Proposal for a regulation Article 14 – paragraph 3 3. The Commission shall inform the Member States, EFSA and the applicant of the outcome of the procedure referred to in paragraph 2. Even if no reasoned safety objections are presented, traditional foods from third countries shall automatically go through a full risk assessment by EFSA at the beginning of the procedure.
Amendment 389 #
Proposal for a regulation Article 14 – paragraph 4 4. Where
Amendment 390 #
Proposal for a regulation Article 14 – paragraph 4 4. Where no reasoned
Amendment 391 #
Proposal for a regulation Article 14 – paragraph 4 4. Where no reasoned safety objections are made in accordance with paragraph 2 within the time-limit laid down in that paragraph, the Commission shall authorise, after a convincing full risk assessment by EFSA, the placing on the market within the Union of the traditional food concerned and update without delay the Union list.
Amendment 392 #
Proposal for a regulation Article 14 – paragraph 4 a (new) 4a. The entry in the Union list shall specify that it concerns a traditional food from a third country.
Amendment 393 #
Proposal for a regulation Article 14 – paragraph 5 – subparagraph 1 Where reasoned safety or environmental and social impact objections, based on scientific
Amendment 394 #
Proposal for a regulation Article 14 – paragraph 5 – subparagraph 1 Where reasoned
Amendment 395 #
Proposal for a regulation Article 15 – paragraph 1 The application provided for in Article 14(5) shall include, in addition to the information already provided in accordance with Article 13, documented data relating to the
Amendment 396 #
Proposal for a regulation Article 16 – paragraph 2 – introductory part 2. In assessing the safety of a traditional food from a third country, EFSA shall consider
Amendment 397 #
Proposal for a regulation Article 16 – paragraph 2 – point a (a) whether the
Amendment 398 #
Proposal for a regulation Article 16 – paragraph 2 – point a (a) whether the history of safe food use in a third country, assessed on the basis of scientific guidelines and clear criteria, is substantiated by reliable data submitted by the applicant in accordance with Articles 13 and 15;
Amendment 399 #
Proposal for a regulation Article 16 – paragraph 2 – point a (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 13 and 15
Amendment 400 #
Proposal for a regulation Article 16 – paragraph 2 – point a (a) whether the history of safe food use in a third country is substantiated by reliable independent scientific data submitted by the applicant in accordance with Articles 13 and 15;
Amendment 401 #
Proposal for a regulation Article 16 – paragraph 2 – point b Amendment 402 #
Proposal for a regulation Article 16 – paragraph 2 – point b Amendment 403 #
Proposal for a regulation Article 16 – paragraph 2 – point b (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 and where applicable to the environment.
Amendment 404 #
Proposal for a regulation Article 16 – paragraph 2 – point b a (new) (ba) whether the novel food meant to replace another food does not have different properties that result in nutritional disadvantages for the consumer;
Amendment 405 #
Proposal for a regulation Article 16 – paragraph 2 – point b b (new) (bb) the overall environmental and social impact of producing, processing, storing and transporting the food.
Amendment 406 #
Proposal for a regulation Article 16 – paragraph 5 5. Where the additional information referred to in paragraph 4 is not
Amendment 407 #
Proposal for a regulation Article 16 – paragraph 5 5. Where the additional information referred to in paragraph 4 is not sent to EFSA within the additional period referred to in that paragraph,
Amendment 408 #
Proposal for a regulation Article 17 – paragraph 1 – subparagraph 1 – introductory part Amendment 409 #
Proposal for a regulation Article 17 – paragraph 1 – subparagraph 1 – introductory part Within three months of the date of publication of EFSA's opinion, the Commission shall
Amendment 410 #
Proposal for a regulation Article 17 – paragraph 1 – subparagraph 1 – introductory part Within three months of the date of publication of EFSA's opinion, the Commission shall submit
Amendment 411 #
Proposal for a regulation Article 17 – paragraph 1 – subparagraph 1 – introductory part Within three months of the date of publication of EFSA's opinion, the Commission shall submit
Amendment 412 #
Proposal for a regulation Article 17 – paragraph 1 – subparagraph 1 – introductory part Within three months of the date of publication of EFSA's opinion, the Commission shall submit to the Committee referred to in Article 27(1) a draft
Amendment 413 #
Proposal for a regulation Article 17 – paragraph 1 – subparagraph 2 Amendment 414 #
Proposal for a regulation Article 17 – paragraph 1 – subparagraph 2 That
Amendment 415 #
Proposal for a regulation Article 17 – paragraph 1 – subparagraph 2 That
Amendment 416 #
Proposal for a regulation Article 17 – paragraph 2 – subparagraph 2 Amendment 417 #
Proposal for a regulation Article 17 – paragraph 3 3. The applicant may withdraw its application referred to in Article 15 at any time before the adoption of EFSA's opinion referred to in Article 16, thereby terminating the procedure for authorising a traditional food from a third country and updating the Union list. In such cases, the applicant shall bear the costs incurred by the EFSA in processing the application.
Amendment 418 #
Proposal for a regulation Article 19 – title Amendment 419 #
Proposal for a regulation Article 19 – paragraph 1 – introductory part By
Amendment 420 #
Proposal for a regulation Article 19 – paragraph 1 – point a (a) the contents, drafting and presentation of the notification provided for in Article 13 and of the application provided for in Article 14(5), including a precise and exhaustive list of documents required for a notification or an application to be valid;
Amendment 421 #
Proposal for a regulation Article 19 – paragraph 1 – point a (a) the
Amendment 422 #
Proposal for a regulation Article 19 – paragraph 1 – point a (a) the contents, drafting and presentation of the notification provided for in Article 13 and of the application provided for in Article 14(5), based on EFSA guidelines;
Amendment 423 #
Proposal for a regulation Article 19 – paragraph 1 – point d Amendment 424 #
Proposal for a regulation Article 19 – paragraph 2 Those
Amendment 425 #
Proposal for a regulation Article 19 – paragraph 2 Those
Amendment 426 #
Proposal for a regulation Article 20 – paragraph 2 2. Where the additional information referred to in paragraph 1 is not received within the extended period referred to in that paragraph, the Commission shall
Amendment 427 #
Proposal for a regulation Article 21 Amendment 428 #
Proposal for a regulation Article 21 a (new) Article 21a Alignment of time periods with Regulation (EC) 1924/2006 If the applicant requests data protection in accordance with Article 24 of this Regulation and Article 21 of Regulation (EC) 1924/2006, the Commission may adjust the time periods provided for in Articles 10(1), 11(1) or (2), 16(1) and 17(1) in order to align them with those in Regulation (EC) 1924/2006 so that the two periods of data protection run concurrently. In such cases the applicant shall be consulted before the Commission takes a decision on the alignment. In addition to this alignment of intellectual property protection periods, health claim and novel food evaluation and authorisation procedures should, where possible, also be synchronised, with a view to ensuring that the market in such products operates smoothly and applicants are afforded proper protection.
Amendment 429 #
Proposal for a regulation Article 22 – paragraph 4 – subparagraph 1 After expiry of the time period referred to in paragraph 3, the Commission may decide after
Amendment 430 #
Proposal for a regulation Article 22 – paragraph 4 – subparagraph 2 – point d (d)
Amendment 431 #
Proposal for a regulation Article 22 – paragraph 4 – subparagraph 2 – point e (e)
Amendment 432 #
Proposal for a regulation Article 22 – paragraph 4 – subparagraph 2 – point e (e)
Amendment 433 #
Proposal for a regulation Article 22 – paragraph 4 – subparagraph 2 – points e a to e d (new) (ea) known risks and restrictions on use; (eb) the methods of analysis; (ec) the scientific literature on which the opinion is based; (ed) toxicological data.
Amendment 434 #
Proposal for a regulation Article 22 – paragraph 4 – subparagraph 2 – point e e (new) (ee) The results of the studies carried out to demonstrate the safety of the food.
Amendment 435 #
Proposal for a regulation Article 22 – paragraph 4 – subparagraph 2 – point e f (new) (ef) information on the detailed chemical composition and health and environmental safety of the food;
Amendment 436 #
Proposal for a regulation Article 22 – paragraph 4 – subparagraph 2 – point e g (new) (eg) any prohibition or restriction imposed in respect of the food by a third country.
Amendment 437 #
Proposal for a regulation Article 22 – paragraph 4 – subparagraph 2 a (new) 2a. The Commission shall maintain a list of applications containing, for each application, the information referred to in points (a) to (e) of the second subparagraph. The Commission shall make that list available to interested parties.
Amendment 438 #
Proposal for a regulation Article 22 – paragraph 5 5. The Commission, the Member States and EFSA shall take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation in accordance with paragraph 4, except for information which is required to be made public in order to protect human health, animal health and welfare, and the environment.
Amendment 439 #
6. Where an applicant withdraws, or has withdrawn, its application, the Commission, the Member States and EFSA shall not disclose confidential information,
Amendment 440 #
Proposal for a regulation Article 22 – paragraph 6 6. Where an applicant withdraws, or has withdrawn, its application, the Commission, the Member States and EFSA shall not disclose confidential information, including information the confidentiality of which is the subject of disagreement between the Commission and the applicant, with the exception of health and environmental safety information.
Amendment 441 #
Proposal for a regulation Article 22 – paragraph 8 Amendment 442 #
Proposal for a regulation Article 22 – paragraph 8 – subparagraph 1 The Commission may, by means of
Amendment 443 #
Proposal for a regulation Article 22 – paragraph 8 – subparagraph 2 Those
Amendment 444 #
Proposal for a regulation Article 23 Amendment 445 #
Proposal for a regulation Article 23 – paragraph 1 1.
Amendment 446 #
Proposal for a regulation Article 23 – paragraph 1 1. The Commission
Amendment 447 #
Proposal for a regulation Article 23 – paragraph 2 – introductory part Amendment 448 #
Proposal for a regulation Article 23 – paragraph 2 – point b (b) any prohibition or restriction based on scientific data and imposed
Amendment 449 #
Proposal for a regulation Article 23 a (new) Article 23a Migration limits for constituents of food contact materials The packaging of novel foods shall comply with the requirements laid down in Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food. When limits on the migration of certain constituents or groups of constituents into or on to food are set in accordance with Article 5 of this Regulation, specific attention shall be paid to food contact materials made from or containing nanomaterials. Not later than (12 months after entry into force of this Regulation), the Commission shall present a report to the European Parliament and the Council on how to address the issue of nanomaterials in food contact materials. This report shall elaborate, inter alia, on what test methods are needed for ascertaining the safety of nanomaterials in food contact materials, whether or not it is appropriate to authorise them, or what migration limits should be set.
Amendment 450 #
Proposal for a regulation Article 23 b (new) Article 23b Privileges of Member States 1. Where a Member State, as a result of new information or a reassessment of existing information, has detailed grounds for considering that the use of a food or a food ingredient complying with this Regulation endangers human health or the environment, that Member State may either temporarily restrict or suspend the trade in and use of the food or food ingredient in question in its territory. It shall immediately inform the other Member States and the Commission thereof, giving the grounds for its decision. 2. The Commission, in close cooperation with EFSA, shall examine the grounds referred to in paragraph 1 as soon as possible and shall take the appropriate measures. The Member State which took the decision referred to in paragraph 1 may maintain it until the measures have entered into force.
Amendment 451 #
Proposal for a regulation Article 24 – paragraph 1 1. On request by the applicant, supported by appropriate and verifiable information included in the application provided for in Article 9(1), newly developed scientific evidence or scientific data supporting the application may not be used for the benefit of a subsequent application during a period of
Amendment 452 #
Proposal for a regulation Article 24 – paragraph 1 1. On request by the applicant, supported by appropriate and verifiable information included in the application provided for in Article 9(1), newly developed scientific evidence or scientific data supporting the application may not be used for the benefit of a subsequent application during a period of
Amendment 453 #
Proposal for a regulation Article 24 – paragraph 1 1. On request by the applicant, supported by appropriate and verifiable information included in the application provided for in Article 9(1), newly developed scientific evidence or scientific data supporting the application may not be used for the benefit of a subsequent application during a period of five years from the date of the authorisation and the inclusion of the novel food in the Union list without the agreement of the prior applicant, unless there is a public health protection justification for doing so.
Amendment 454 #
Proposal for a regulation Article 24 – paragraph 2 – subparagraph 1 – point a (a) the newly developed scientific evidence or scientific data was designated as proprietary by the
Amendment 455 #
Proposal for a regulation Article 24 – paragraph 2 – subparagraph 1 – point b (b) the prior applicant
Amendment 456 #
Proposal for a regulation Article 24 – paragraph 2 – subparagraph 1 – point b (b) the prior applicant had exclusive right of reference to the proprietary scientific evidence or scientific data at the time the first application was made, whether or not the data was published, and
Amendment 457 #
Proposal for a regulation Article 24 – paragraph 3 a (new) 3a. In order to avoid the repetition of studies involving vertebrates, reference by a subsequent applicant to studies on vertebrates and other studies that may prevent animal testing shall be allowed. The owner of the data may claim adequate compensation for the use of the data.
Amendment 458 #
Proposal for a regulation Article 25 – paragraph 1 – introductory part 1. Where a novel food is authorised and included in the Union list based on proprietary scientific evidence or scientific data that are granted data protection as provided for in Article 24(1), the entry of a novel food in the Union list shall indicate, in addition to the information referred to in Article 8(3) and Article 22(4):
Amendment 459 #
Proposal for a regulation Chapter 6 – title Penalties and
Amendment 460 #
Proposal for a regulation Chapter 6 – title Penalties and
Amendment 461 #
Proposal for a regulation Article 26 a (new) Article 26a Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 11(1) shall be conferred on the Commission for an indeterminate period of time. 3. The delegation of power referred to in Article 11(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 11(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of the act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council.
Amendment 462 #
Proposal for a regulation Article 26 b (new) Amendment 463 #
Proposal for a regulation Article 26 c (new) Article 26c Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 3, Article 9(3), Article 11(1), Article 17(1) and Article 29(3) shall be conferred on the Commission for a period of seven years from ...*. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the seven-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council oppose such extension no later than three months before the end of each period. 3. The delegation of power referred to in Article 3, Article 9(3), Article 11(1), Article 17(1) and Article 29(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 3, Article 9(3), Article 11(1), Article 17(1) and Article 29(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of the act to the European Parliament and the Council or if, before the expiry of that period, The European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. _______________ *OJ: please insert the date of entry into force of this Regulation.
Amendment 464 #
Proposal for a regulation Article 27 – title Amendment 465 #
Proposal for a regulation Article 27 – paragraph 1 Amendment 466 #
Proposal for a regulation Article 27 – paragraph 1 a (new) 1a. Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The delegation of power referred to in Article 3, Article 9(3), Article 11(1), Article 17(1) and Article 29(3) shall be conferred on the Commission for a period of seven years from the date of entry into force of this Regulation. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the seven-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council oppose such extension no later than three months before the end of each period. 3. The delegation of power referred to in in Article 3, Article 9(3), Article 11(1), Article 17(1) and Article 29(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 3, Article 9(3), Article 11(1), Article 17(1) and Article 29(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months from the notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Amendment 467 #
Proposal for a regulation Article 27 – paragraph 2 – subparagraph 1 Amendment 468 #
Proposal for a regulation Article 27 – paragraph 2 – subparagraph 2 Amendment 469 #
Proposal for a regulation Article 27 – paragraph 2 – subparagraph 2 Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result
Amendment 470 #
Proposal for a regulation Article 27 – paragraph 3 – subparagraph 1 Amendment 471 #
Proposal for a regulation Article 27 – paragraph 3 – subparagraph 1 Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011
Amendment 472 #
Proposal for a regulation Article 27 – paragraph 3 – subparagraph 1 Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. The committee shall deliver its opinion within six months after adoption of the proposal referred to in Articles 11(1) and 17(1).
Amendment 473 #
Amendment 474 #
Proposal for a regulation Article 27 – paragraph 3 – subparagraph 2 Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result
Amendment 475 #
1. Any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 and for which the final decision has not been taken before …27 shall be considered as an application under this Regulation. __________________ 27 Publications Office: please insert date: 12
Amendment 476 #
Proposal for a regulation Article 29 – paragraph 2 – point b (b) If no
Amendment 477 #
Proposal for a regulation Article 29 – paragraph 2 – point c (c) If
Amendment 478 #
Proposal for a regulation Article 29 – paragraph 3 Amendment 479 #
Proposal for a regulation Article 29 – paragraph 3 3. The Commission may, by means of
Amendment 480 #
Proposal for a regulation Article 29 – paragraph 3 3. The Commission may, by means of
Amendment 481 #
Proposal for a regulation Article 29 – paragraph 3 a (new) 3a. Where a novel food authorised under Article 4 of Regulation (EC) No 258/97 is included on the Union list in accordance with Article 7, the marketing of that novel food in the Union shall be granted exclusively to the applicant for a period of 10 years from the date of authorisation, unless a subsequent applicant obtains an authorisation for that novel food.
Amendment 482 #
Proposal for a regulation Article 29 a (new) Article 29a Until specific legislation on food derived from cloned animals and their descendants enters into force, this food while placed on the market within the Union shall be accompanied by the following information for the final consumer: "Food derived from cloned animals/ descendants of cloned animals." In the case of pre-packed food, this food information shall be provided by means of a label. In all other cases, this food information shall be provided by other accompanying material.
Amendment 483 #
Proposal for a regulation Article 29 b (new) Article 29b Reporting Five years after its entry into force, the Commission shall report to the European Parliament and to the Council about the implementation of this Regulation, addressing in particular the impact of the new simplified procedure on traditional foods from third countries.
Amendment 484 #
Proposal for a regulation Article 30 – paragraph 2 It shall apply from …28 . __________________ 28 Publications Office: please insert date: 12
Amendment 485 #
Proposal for a regulation Article 30 – paragraph 2 a (new) Annex Union list of novel foods and conditions of use
Amendment 486 #
Proposal for a regulation Article 30 a (new) Article 30 a Annex Union list of authorised novel foods and list of traditional foods from third countries.
Amendment 94 #
Proposal for a regulation Citation 2 a (new) Having regard to the positions of both Council and European Parliament on 29 March 2011, when the conciliation on novel foods failed;
Amendment 95 #
Proposal for a regulation Recital 1 (1) The free movement of
Amendment 96 #
Proposal for a regulation Recital 2 (2) A high level of protection of human health and of consumers’ interests, of the environment and animal welfare, and the effective functioning of the internal market should be assured in the pursuit of Union food policies, whilst ensuring transparency.
Amendment 97 #
Proposal for a regulation Recital 2 (2) A high level of protection of human health and of consumers’ interests, of the environment and animal welfare, and the
Amendment 98 #
Proposal for a regulation Recital 2 (2) A high level of protection of human health, based on the precautionary principle, and of consumers’ interests and the effective functioning of the internal market
Amendment 99 #
Proposal for a regulation Recital 3 (3) The Union’s rules on novel foods were established by Regulation (EC) No 258/97 of the European Parliament and of the Council8 and by Commission Regulation (EC) No 1852/20019. Those rules need to be updated to simplify the current authorisation procedures, improve consumer safety and
source: 539.826
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