Activities of Hiltrud BREYER related to 2008/0002(COD)
Plenary speeches (1)
Novel foods (debate)
Amendments (45)
Amendment 43 #
Proposal for a regulation
Recital 1
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 to their social and economic interests. Differences between national laws, regulations and administrative provisions concerning the safety assessment and authorisation of novel foods may hinder their free movement, thereby potentially creating unfair competition conditions.
Amendment 44 #
Proposal for a regulation
Recital 2
Recital 2
(2) A high level of human health and consumer protection should be assured in the pursuit of Community policies as well as a high level of animal welfare and environmental protection. At all times, the precaution principle should apply.
Amendment 45 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
2a. Article 13 of the Treaty on the Functioning of the European Union clarifies that the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare requirements of animals when formulating and implementing policies
Amendment 46 #
Proposal for a regulation
Recital 2 b (new)
Recital 2 b (new)
2b. European Parliament resolution of 3 September 2008 on the cloning of animals for food supply calls on the Commission to submit proposals prohibiting for food supply purposes (i) the cloning of animals, (ii) the farming of cloned animals or their offspring, (iii) the placing on the market of meat or dairy products derived from cloned animals or their offspring and (iv) the importing of cloned animals, their offspring, semen and embryos from cloned animals or their offspring, and meat or dairy products derived from cloned animals or their offspring.
Amendment 47 #
Proposal for a regulation
Recital 2 c (new)
Recital 2 c (new)
2c. The Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) adopted on 28-29 September 2005 an opinion which concluded that there are ‘major gaps in the knowledge necessary for risk assessment. These include nanoparticle characterisation, the detection and measurement of nanoparticles, the dose-response, fate, and persistence of nanoparticles in humans and in the environment, and all aspects of toxicology and environmental toxicology related to nanoparticles’; furthermore draws attention to the conclusion of SCENIHR that ‘existing toxicological and ecotoxicological methods may not be sufficient to address all of the issues arising with nanoparticles’;
Amendment 53 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) Test methods currently available are not adequate for assessing the risks associated with nanomaterials. Nano- specific non-animal test methods should urgently be developed. In order to protect human health and prevent animal testing, the use of nanotechnologies in food production should be prohibited until such a time as sufficient nano-specific non-animal test methods have been approved for use and an adequate safety assessment on the basis of these tests has been carried out.
Amendment 60 #
Proposal for a regulation
Recital 14
Recital 14
(14) Novel foods should be placed on the Community market only if they are safe and, do not mislead the consumer, and show clear benefits for the consumers. In addition, they should not differ from the food that they are to replace in any way that would be nutritionally disadvantageous for the consumer.
Amendment 61 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
Amendment 63 #
Proposal for a regulation
Recital 18
Recital 18
(18) Where appropriate andOn the basedis onf the conclusions of the safety assessment, post- market monitoring requirements for the use of novel foods for human consumption should be introduced.
Amendment 65 #
Proposal for a regulation
Recital 20
Recital 20
(20) Under specific circumstances in order to stimulate research and development within the agri-food industry, and thus innovation, the newly developed scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the Community list should not be used to the benefit of another applicant during a limited period of time, without the agreement of the first applicant. The protection of scientific data provided by one applicant should not prevent other applicants from seeking the inclusion in the Community list of novel foods on the basis of their own scientific data. However, the repetition of studies involving vertebrates should be prohibited. In this context, there should be an obligation to allow access to studies on vertebrates and other studies that may prevent animal testing.
Amendment 68 #
Proposal for a regulation
Recital 21
Recital 21
(21) Novel foods are subject to the general labelling requirements laid down in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to labelling, presentation and advertising of foodstuffs. In certain cases it might be necessary to provide for additional labelling information, in particular regarding the description of the food, its source, or its conditions of use. Therefore, the inclusion of a novel food in the Community list maywill impose specific conditions of use or labelling obligations in those cases. Products produced with the aid of nanotechnologies and food produced from animals fed with genetically modified feedingstuffs must be labelled as such.
Amendment 75 #
Proposal for a regulation
Article 1
Article 1
This Regulation lays down harmonised rules for the placing of novel foods on the market in the Community with a view to ensuring a high level of human health and consumers’ protection, whilst ensuringprotection of human life and health, animal health and welfare, the environment and the interests of consumers, whilst ensuring transparency and the effective functioning of the internal market.
Amendment 81 #
Proposal for a regulation
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2a. Notwithstanding paragraph 2, this Regulation shall apply to food additives, food enzymes, flavourings and certain food ingredients with flavouring properties to which is applied a new production process not used before 15 May 1997 giving rise to significant changes in the composition or structure of the food (e.g. nanotechnologies). If novel foods can also have the impact of an additive or flavouring in a food product, they should be covered by both this regulation and the food additives legislation or the food flavourings legislation.
Amendment 89 #
Proposal for a regulation
Article 3 – paragraph 2 - point (a) (iii)
Article 3 – paragraph 2 - point (a) (iii)
(iii) food to which is applied a new production process, not used before 15 May 1997,in a significant way in the Community before 15 May 1997, - definitely including, but not confined to, foods produced with the aid of nanotechnologies - where that production process gives rise to significant changes in the composition or structure of the food which affect its nutritional value, metabolism or level of undesirable substances.;
Amendment 95 #
Proposal for a regulation
Article 3 – paragraph 2 - point (c a) (new)
Article 3 – paragraph 2 - point (c a) (new)
(ca) ‘produced with the aid of nanotechnologies’: a product which contains, consists of or is produced with the aid of substances in the order of 300 nm in length, breadth or height and/or substances that exhibit, due to their reduced particle size, novel characteristics compared to the common form.
Amendment 104 #
Proposal for a regulation
Article 5
Article 5
Only novel foods included in the Community list of novel foods (hereinafter "the Community list") may be placed on the market. The Commission shall keep and publish the Community list on a publicly accessible page intended for the purpose on the website of the Commission.
Amendment 107 #
Proposal for a regulation
Article 6 – introduction
Article 6 – introduction
1. A novel food may be included in the Community list only if it meets the following conditions:
Amendment 108 #
Proposal for a regulation
Article 6 – point (a)
Article 6 – point (a)
(a) it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer under normal consumption conditions; this implies that cumulative and synergistic effects as well as possible adverse effects on particular groups of the population will be taken into account in the risk assessment; Or. en Justification
Amendment 111 #
Proposal for a regulation
Article 6 – point (c a) (new)
Article 6 – point (c a) (new)
(ca) it shows clear benefits for consumers;
Amendment 112 #
Proposal for a regulation
Article 6 – point (c b) (new)
Article 6 – point (c b) (new)
(cb) its use does not have a negative impact on the environment, nor does its use produce residues or undigested substances that are persistent and accumulative or have in any other way a negative impact on the environment;
Amendment 116 #
Proposal for a regulation
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2a. Foods to which production processes have been applied that require specific risk assessment methods (e.g. nanotechnologies) may not be included in the Community list until such specific methods have been approved for use, and an adequate safety assessment on the basis of these methods has shown that the use of the respective foods is safe. These methods must not entail the use of vertebrate animals.
Amendment 117 #
Proposal for a regulation
Article 6 – paragraph 3 a (new)
Article 6 – paragraph 3 a (new)
3a. In case of doubt, e.g. if there is insufficient scientific certainty or lack of data, the precautionary principle shall be applied and the food in question can not be included in the Community list.
Amendment 119 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
(2) The entry of a novel food in the Community list shall include: (a) a specification of the food, and, where appropriate, specify the conditions of use, additional specific labelling requirements to inform the final consumer and/or a post-market monitoring requirement; (b) the intended use of the food; (c) the conditions of use; (d) the date of entry of the novel food in the Community list and the date of receipt of the application; (e) the name and address of the applicant; (f) the date and results of the last inspection according to the monitoring requirements laid down in Article 11.
Amendment 124 #
Proposal for a regulation
Article 7 – paragraph 2 a – subparagraph 1 (new)
Article 7 – paragraph 2 a – subparagraph 1 (new)
2a. Novel Foods are subject to the general labelling requirements laid down in Directive 2000/13/EC. Additional specific labelling requirements may be laid down for specific novel foods, in particular regarding the description of the food, its source, or its conditions of use. Where this is the case, the labelling requirement shall be mentioned in the Community list.
Amendment 125 #
Proposal for a regulation
Article 7 – paragraph 2 a – subparagraph 2 (new)
Article 7 – paragraph 2 a – subparagraph 2 (new)
Products produced with the aid of nanotechnologies must be labelled with the words ‘produced with the aid of nanotechnologies’;
Amendment 126 #
Proposal for a regulation
Article 7 – paragraph 2 a – subparagraph 3 (new)
Article 7 – paragraph 2 a – subparagraph 3 (new)
Products produced from animals fed with genetically modified feedingstuffs must be labelled with the words ‘produced from animals fed with genetically modified feedingstuffs’;
Amendment 128 #
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
Amendment 140 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. A food business operator intending to place a traditional food from a third country on the market in the Community shall notify itsubmit an application to the Commission, indicating the name of the food, its composition and country of origin. The notifapplication shall be accompanied by a dossier with documented data demonstrating the history of safe food use in the third country based on the guidelines referred to in paragraph 5a.
Amendment 142 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. The Commission shall forward the notification including the demonstration of history of safe food use referred to in paragraph 1 without delay to the Member States and the Authority and make it publicly available on its website.
Amendment 144 #
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. Within fourThe Authority shall, on the basis of the requirements specified in Article 6 and taking into consideration the dossier provided by the food business operator, assess whether the food is safe and can be placed on the European market. Within six months from the date on which the notification provided for in paragraph 2 is forwarded by the Commission, a Member State and/ or the Authority may inform the Commission that they have reasoned safety objections, based on scientific evidence, to the placing on the market of the traditional food concerned.
Amendment 149 #
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. The Commission shall publish a list of traditional foods from third countries that may be placed on the market in the Community in accordance with paragraph 4 on a dedicated page of the Commission's website. This page shall be accessible from and linked to the page on the Community list on novel foods referred to in Article 5 paragraph 1.
Amendment 150 #
Proposal for a regulation
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (new)
Amendment 152 #
Proposal for a regulation
Article 9
Article 9
The Commission shall, where appropriate, in close cooperation with the Authority, make available technical guidance and tools to assist food business operators and especially small and medium-sized enterprises in preparing and submitting applications under this Regulation. The technical guidance and tools shall be published, not later than six months after the date of entry into force of this Regulation, on a publicly accessible page intended for the purpose on the website of the Commission.
Amendment 156 #
Proposal for a regulation
Article 10 – introduction
Article 10 – introduction
In assessing the safety of novel foods, the Authority shall, on the basis of the requirements specified in Article 6:
Amendment 157 #
Proposal for a regulation
Article 10 – point (a)
Article 10 – point (a)
(a) compare, where appropriatpossible, if the food is as safe as food from a comparable food category already existing on the market in the Community or as the food that the novel food is intended to replace; while also taking into account the implications of any new characteristics;
Amendment 162 #
Proposal for a regulation
Article 10 – point (b)
Article 10 – point (b)
(b) take into account for traditional food from a third country, the history of safe food use.; thereby referring to the guidelines laid down in Article 8, paragraph 5a;
Amendment 165 #
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. The Commission mayshall impose for food safety reasons and following the opinion of the Authority, a requirement for post- market monitoring. The food business operators placing the food in the Community market shall be responsible for the implement requirement for post- market monitoring. This monitoring shall take place every five years and take into account food safety aspects as well as animal health and welfare aspects and the environmental impact. Special attention should be paid to the categories of the population ofwith the post- marketing requirements specified in the entry of the food concerned in the Community list of novel foodhighest dietary intakes. The monitoring requirements shall also apply to novel foods already on the market, including novel foods that have been approved under the simplified procedure ('notification') of Regulation (EC) No 258/97. Member States shall appoint competent authorities that will be responsible for the post-marketing monitoring. The costs for the monitoring shall be covered by the respective food business operators.
Amendment 168 #
Proposal for a regulation
Article 11 - paragraph 2 a (new)
Article 11 - paragraph 2 a (new)
2a. In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort. The use of non-animal tests and intelligent testing strategies shall be promoted, and duplicate vertebrate animal testing shall be prohibited.
Amendment 172 #
Proposal for a regulation
Article 12
Article 12
1. On request by the applicant, supported by appropriate and verifiable information included in the application dossier, newly developed scientific evidence and proprietary scientific data provided to support the applications, may not be used for the benefit of another application during a period of five years from the date of the inclusion of the novel food in the Community list without the agreement of the applicant unless there is a public health protection justification for doing so.
Amendment 177 #
Proposal for a regulation
Article 12 – paragraph 1 a (new)
Article 12 – paragraph 1 a (new)
1a. Data from research projects partly or completely paid by the EC and/or public institutions and risk studies or data related to risk studies, like feeding studies should be published together with the application and are free to be used by other applicants.
Amendment 178 #
Proposal for a regulation
Article 12 – paragraph 1 b (new)
Article 12 – paragraph 1 b (new)
1b. In any circumstance, the repetition of studies involving vertebrates will be prohibited. In this context, studies involving tests on vertebrate animals and studies that may prevent animal testing will not be covered by data protection. Thus access to studies on vertebrates and other studies that may prevent animal testing must be allowed.
Amendment 183 #
Proposal for a regulation
Article 12 a (new)
Article 12 a (new)
Article 12a Inspection and control measures In order to enforce compliance with the present Regulation, official controls are to be carried out in accordance with 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.
Amendment 186 #
Proposal for a regulation
Article 13
Article 13
The Member States shall lay down the rules on penalties applicable to infringements of the provision 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. The Member States shall notify those provisions to the Commission by [..] at the latest and shall notify it without delay of any subsequent amendment affecting them. This information shall be made available to the public by the Commission.
Amendment 187 #
Proposal for a regulation
Article 13 a (new)
Article 13 a (new)
Article 13a 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 190 #
Proposal for a regulation
Article 18 – paragraph 2 a (new)
Article 18 – paragraph 2 a (new)
2a. Food products that have been produced with the aid of nanotechnologies and that have been placed on the market before the entry into force of this Regulation may remain on the market for 18 months after the date of publication of this Regulation. After that date, Article 6 paragraph 2 shall apply.