Activities of Bart STAES related to 2013/0435(COD)
Plenary speeches (1)
Novel foods (debate) NL
Shadow reports (1)
PDF (1 MB) DOC (928 KB)
Amendments (85)
Amendment 94 #
Proposal for a regulation
Citation 2 a (new)
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 96 #
Proposal for a regulation
Recital 2
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. At all times, moreover, the precautionary principle as laid down in 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[1], should be applied. Or. en ([1] OJ L 31, 1.2.2002, p. 1.)
Amendment 113 #
Proposal for a regulation
Recital 7
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 . __________________ 16Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulation (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directive 2002/67/EC and 2008/5/EC and Commission Regulation (EC No 608/2004 (OJ L 304, 22.11.2011, p. 18).
Amendment 120 #
Proposal for a regulation
Recital 8 a (new)
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 132 #
Proposal for a regulation
Recital 12
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, the food should not be considered to be traditional.
Amendment 136 #
Proposal for a regulation
Recital 15
Recital 15
Amendment 138 #
Proposal for a regulation
Recital 16
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, 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 should be established for collecting such information.
Amendment 143 #
Proposal for a regulation
Recital 17
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
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 implementing act, a Union list of novel foods by entering novel foods already authorised or notified in accordance with Article 4, 5 or 7 of Regulation (EC) No 258/97 in the Union list, including any existing authorisation conditions. As those novel foods have already been evaluated for their safety, have been legally produced and marketed in the Union and have not given rise to health concerns in the past, the advisory procedure should be used for the initial establishment of the Union list.
Amendment 150 #
Proposal for a regulation
Recital 19
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 conferrThe power to adopt acts in accordance with Article 290 TFEU should therefore be delegated ton the Commission, in that respecorder to update the list.
Amendment 159 #
Proposal for a regulation
Recital 21
Recital 21
(21) As regards the possible use of nanomaterials for food use, EFSA consideracknowledged 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 the test methods currently available might not be adequate for assessing the risks associated with nanomaterials and considered, more specifically, 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 developingshall therefore develop non-animal test methods which take into account specific characteristics of engineered nanomaterials. __________________ 21 as a matter of urgency. __________________ 21 EFSA Journal 2011;9(5):2140. EFSA Journal 2011;9(5):2140.
Amendment 162 #
Proposal for a regulation
Recital 21 a (new)
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)
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)
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)
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
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 should be introduced 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 172 #
Proposal for a regulation
Recital 24 b (new)
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 175 #
Proposal for a regulation
Recital 27
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, implementing powersthe power to adopt delegated acts in accordance with Article 290 TFEU should be conferred on the Commission.
Amendment 180 #
Proposal for a regulation
Recital 28
Recital 28
(28) The implementing powers relating to the definition of ‘novel food’, the consultation process for determination of novel food status, other updates of the Union list, the drafting and presentation of applications or notifications for the inclusion of foods in the Union list, the arrangements for checking the validity of applications or notifications, confidentiality treatment and transitional provisions, should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council22 . __________________ 22 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 183 #
Proposal for a regulation
Recital 28 a (new)
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 185 #
Proposal for a regulation
Recital 28 c (new)
Recital 28 c (new)
Amendment 190 #
Proposal for a regulation
Article 1 – paragraph 1 b (new)
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 193 #
Proposal for a regulation
Article 1 – paragraph 2 – point c
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]derived from cloned animals and their descendants. Until specific legislation on such food enters into force, no food from cloned animals and their descendants shall be placed on the market.
Amendment 206 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point i
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 226 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point ii
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 1169/2011any intentionally manufactured material containing particles, in an unbound state or as an aggregate or agglomerate and where, for 10% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1nm to 100nm;
Amendment 232 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point iii – indent 2
Article 2 – paragraph 2 – point a – point iii – indent 2
– such substances contain or consist of ‘engineered nanomaterials’ as defined in Article 2(2)t of Regulation (EU) No 1169/2011any intentionally manufactured material containing particles, in an unbound state or as an aggregate or agglomerate and where, for 10% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1nm to 100nm;
Amendment 249 #
Amendment 262 #
Proposal for a regulation
Article 4 – paragraph 2
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 in particular the extent to which the food in question was used for human consumption within the Union before 15 May 1997whether or not a food falls within the scope of this Regulation. With a view to determining that assessment, the Member State shall consult the Commission and the other Member States.
Amendment 266 #
Proposal for a regulation
Article 4 – paragraph 3 – subparagraph 1
Article 4 – paragraph 3 – subparagraph 1
The Commission may, by means of implementdelegated acts ing actscordance with Article 26 a, specify the procedural steps of the consultation process provided for in paragraph 2.
Amendment 268 #
Proposal for a regulation
Article 4 – paragraph 3 – subparagraph 2
Article 4 – paragraph 3 – subparagraph 2
Amendment 272 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
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’) is laid down in the Annex.
Amendment 277 #
Proposal for a regulation
Article 5 – paragraph 2 b (new)
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)
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
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 282 #
Proposal for a regulation
Article 6 – paragraph 1 – point b
Article 6 – paragraph 1 – point b
(b) its use does not mislead the consumer, but offers benefits to consumers;
Amendment 287 #
Proposal for a regulation
Article 6 – paragraph 1 a (new)
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)
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
Article 7 – paragraph 1
No later than …23 the Commission shall, by means of an implementing act, establish the Union list by entering novel foods authorised or notified under Articles 4, 5 or 7 of Regulation (EC) N° 258/97 in the Union listare listed in the Annex to this Regulation, including any existing authorisation conditions. __________________ 23Publications Office: please insert date: 24 months after the entry into force of this Regulation.
Amendment 297 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
Amendment 307 #
Proposal for a regulation
Article 8 – paragraph 3 – introductory part
Article 8 – paragraph 3 – introductory part
3. The entry for a novel food in the Union list provided for in paragraph 2 shall include where relevant:
Amendment 310 #
Proposal for a regulation
Article 8 – paragraph 3 – point a a (new)
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)
Article 8 – paragraph 3 – point a b (new)
(ab) the name and address of the applicant;
Amendment 313 #
Proposal for a regulation
Article 8 – paragraph 3 – point b
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
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 316 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1
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 325 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Commission may request EFSA to render its opinion if the update is liable to have an effect on human healthshall forward the valid application to EFSA and request EFSA to render its opinion.
Amendment 332 #
Proposal for a regulation
Article 9 – paragraph 2 b (new)
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 337 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The procedure forCommission shall be empowered to adopt delegated acts, in accordance with Article 26 (a) concerning the authorisingation of the placing on the market within the Union of a novel foods and the updating of the Union list as provided for in Article 8 shall end with the adoption of an implementing act in accordance with Article 11list laid down in the Annex.
Amendment 339 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1
Article 10 – paragraph 1 – subparagraph 1
Amendment 341 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 2 – introductory part
Article 10 – paragraph 1 – subparagraph 2 – introductory part
In assessing the safety of novel foods, EFSA shall, where appropriate, consider the following:
Amendment 346 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 2 – point b a (new)
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)
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 356 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1 – introductory part
Article 11 – paragraph 1 – subparagraph 1 – introductory part
Within nine months from the date of publication of EFSA's opinion, the Commission shall submit to the committee referred to in Article 27(1) a draft implementbe empowered to present a draft delegated act ing actcordance with Article 26(a) updating the Union list taking account of:
Amendment 359 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 2
Article 11 – paragraph 1 – subparagraph 2
Amendment 365 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
Amendment 372 #
Proposal for a regulation
Article 12 – paragraph 1 – point a
Article 12 – paragraph 1 – point a
(a) the contents, drafting and presentation of the application referred to in Article 9(1);
Amendment 373 #
Proposal for a regulation
Article 12 – paragraph 1 – point c
Article 12 – paragraph 1 – point c
Amendment 385 #
Proposal for a regulation
Article 14 – paragraph 1
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 387 #
Proposal for a regulation
Article 14 – paragraph 2
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 safety objections regarding its compliance with Article 6, based on scientific evidence, to the placing on the market within the Union of the traditional food concerned.
Amendment 390 #
Proposal for a regulation
Article 14 – paragraph 4
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 Union list. Where applicable, certain conditions for use, specific labelling requirements, or post- market monitoring requirements shall be specified.
Amendment 392 #
Proposal for a regulation
Article 14 – paragraph 4 a (new)
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 394 #
Proposal for a regulation
Article 14 – paragraph 5 – subparagraph 1
Article 14 – paragraph 5 – subparagraph 1
Where reasoned safety objections, based on scientific evidence, are submitted to the Commission in accordance with paragraph 2, the Commission shall not authorise the placing on the market of the traditional food concerned nor update the Union list.
Amendment 396 #
Proposal for a regulation
Article 16 – paragraph 2 – introductory part
Article 16 – paragraph 2 – introductory part
2. In assessing the safety of a traditional food from a third country, EFSA shall consider the following matters:(To be voted together with amendment on Article 16(2)(a).)
Amendment 399 #
Proposal for a regulation
Article 16 – paragraph 2 – point a
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; as well as requirements laid down in Article 10 (1).
Amendment 402 #
Proposal for a regulation
Article 16 – paragraph 2 – point b
Article 16 – paragraph 2 – point b
Amendment 409 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 1 – introductory part
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 implementing actbe empowered to submit a draft delegated act in accordance with Article 26 (a) to authorise the placing on the market within the Union of the traditional food from a third country and to update the Union list, taking into account the following:
Amendment 413 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 2
Article 17 – paragraph 1 – subparagraph 2
Amendment 421 #
Proposal for a regulation
Article 19 – paragraph 1 – point a
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);
Amendment 423 #
Proposal for a regulation
Article 19 – paragraph 1 – point d
Article 19 – paragraph 1 – point d
Amendment 429 #
Proposal for a regulation
Article 22 – paragraph 4 – subparagraph 1
Article 22 – paragraph 4 – subparagraph 1
After expiry of the time period referred to in paragraph 3, the Commission may decide after consulting withhaving heard the applicants which information may remain confidential and, in the case a decision has been taken, shall notify the Member States and the applicants accordingly.
Amendment 434 #
Proposal for a regulation
Article 22 – paragraph 4 – subparagraph 2 – point e e (new)
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 438 #
Proposal for a regulation
Article 22 – paragraph 5
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 441 #
Proposal for a regulation
Article 22 – paragraph 8
Article 22 – paragraph 8
Amendment 445 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
1. The Commission may, for food safety reasons and taking into account the opinion of EFSA, impose aA requirement for post-market monitoring of ashall be imposed for all novel foods to ensure that the use of the authorised novel food is within safe limits.
Amendment 449 #
Proposal for a regulation
Article 23 a (new)
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 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 453 #
Proposal for a regulation
Article 24 – paragraph 1
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 457 #
Proposal for a regulation
Article 24 – paragraph 3 a (new)
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 459 #
Proposal for a regulation
Chapter 6 – title
Chapter 6 – title
Penalties and committee proceduregeneral provisions
Amendment 462 #
Proposal for a regulation
Article 26 b (new)
Article 26 b (new)
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: 124 months after the date of entry into force of this Regulation.
Amendment 478 #
Proposal for a regulation
Article 29 – paragraph 3
Article 29 – paragraph 3
Amendment 484 #
Proposal for a regulation
Article 30 – paragraph 2
Article 30 – paragraph 2
It shall apply from …28 . __________________ 28 Publications Office: please insert date: 124 months after the date of entry into force of this Regulation.
Amendment 485 #
Proposal for a regulation
Article 30 – paragraph 2 a (new)
Article 30 – paragraph 2 a (new)
Annex Union list of novel foods and conditions of use