25 Amendments of Stefan ECK related to 2013/0435(COD)
Amendment 39 #
Proposal for a regulation
Recital 2
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 41 #
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 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 94 #
Proposal for a regulation
Recital 24
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 104 #
Proposal for a regulation
Article 1 – paragraph 1
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, while providing a high level of protection of human health and consumer interestsst ensuring transparency and, where relevant, the protection of the environment and animal health and welfare.
Amendment 110 #
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]. 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 143 #
Proposal for a regulation
Article 2 – paragraph 2 – point e a (new)
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)
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 179 #
Proposal for a regulation
Article 6 – paragraph 1 – point c a (new)
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 194 #
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]. 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 201 #
Proposal for a regulation
Article 8 – paragraph 3 – point c
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 214 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point c
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 220 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Commission mayshall request EFSA to render its opinion if the update is liable to have an effect on human health. , animal health and welfare, or the environment.
Amendment 232 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 2 – point b
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 241 #
Proposal for a regulation
Article 2 – paragraph 2 – point b
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 246 #
Proposal for a regulation
Article 2 – paragraph 2 – point e a (new)
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)
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)
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 261 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Food business operators shall consult athe Member State where they first intend to place the novel food in the market if 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 1997.
Amendment 284 #
Proposal for a regulation
Article 22 – paragraph 4 – subparagraph 2 – point d
Article 22 – paragraph 4 – subparagraph 2 – point d
(d) a summary of the studies submitted by the applicant;
Amendment 305 #
Proposal for a regulation
Article 29 – paragraph 3 a (new)
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 309 #
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 351 #
Proposal for a regulation
Article 10 – paragraph 4
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, it shall finalise its opinion on the basis of the information already provided to itthe procedure shall be suspended and a justification on the reasoning of this suspension shall be communicated by EFSA to the applicant, the Commission and the Member States.
Amendment 383 #
Proposal for a regulation
Article 13 – paragraph 2 – point e
Article 13 – paragraph 2 – point e
(e) where applicable, the conditions of use and specific labelling requirements, which do not mislead the consumer. and, where applicable, the maximum recommended intake and any possible adverse effects for specific groups
Amendment 407 #
Proposal for a regulation
Article 16 – paragraph 5
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 finalise its opinion on the basis of the information already provided to itthe procedure shall be suspended and a justification on the reasoning of this suspension shall be communicated by EFSA to the applicant, the Commission and the Member States.
Amendment 446 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
1. The Commission mayshall, for food safety reasons and taking into account the opinion of EFSA,in line with the precautionary principle impose a requirement for post- market monitoring of afor all novel food, taking into account the opinion of EFSA for establishing the necessary period, in order to ensure that the use of the authorised novel food is within safe limits.