BETA

22 Amendments of Niels BUSK related to 2008/0002(COD)

Proposal for a regulation − amending act
Recital 5

(5) The existing definition of novel food should be clarified, with an explanation of the criteria for novelty, and updated by replacing the existing categories, with a reference to the general definition of food 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.

2008/06/27
Committee: AGRI

Proposal for a regulation − amending act
Recital 6

(6) The scope of this Regulation should include all foods which have not been used for human consumption to a significant degree within the Community before 15 May 1997. The criteria for novelty in relation to food should include the use of new species of organisms such as plants, animals, microorganisms, fungi or algae. Also the use of new parts of existing organisms and substances with a new molecular structure should be regarded as novel foods. An existing food should be considered novel if it has been modified in a way that changes its chemical composition, molecular structure, particle size or other elements, in a way that is likely to have an impact on food safety. It should also be clarified that a food should be considered as novel when it is applied a production technology, which was not previously used. In particular, emerging technologies in breeding and food production processes, which have an impact on food and thus might have an impact on food safety, should be covered by this Regulation. Novel food should therefore include foods derived from plants and animals, produced by non-traditional breeding techniques, and foods modified by new production processes, such as nanotechnology and nanoscience which might have an impact on food safety. Food derived from new plant varieties, or animal breeds produced by traditional breeding techniques, should not be considered as novel foods.

2008/06/27
Committee: AGRI

Proposal for a regulation − amending act
Recital 7

(7) I~~f necessary, i~~mplementing measures should be adopted to provide for further criteria in order to facilitate the assessment of whether a food has been used for human consumption to a significant degree within the Community before 15 May 1997. If a food has been used exclusively as or in a food supplement, as defined in Directive 2002/46/EC, prior that date, it can be placed on the market after that date for the same use without being considered as a novel food. However, that use as or in a food supplement should not be taken into account for the assessment whether it has been used for human consumption to a significant degree within the Community before 15 May 1997. Therefore, other uses of the food concerned, e.g. other than food supplement uses, have to be authorised in accordance with this Regulation.

2008/06/27
Committee: AGRI

Proposal for a regulation − amending act
Recital 8 a (new)

(8a) The provisions of Directive 2001/83/EC on the Community code relating to medicinal products for human use1 should apply where, taking into account all its characteristics, a product may fall within the definition of "medicinal product" and within the definition of a product covered by other Community legislation. In this respect, a Member State may, if it establishes in accordance with Directive 2001/83/EC that a substance is a medicinal product, restrict the placing on the market of such product in accordance with Community law. 1 OJ L 311, 28.11.2001, p. 67.

2008/06/27
Committee: AGRI

Proposal for a regulation − amending act
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, which may include information relating to ethical considerations. Therefore, the inclusion of a novel food in the Community list may impose specific conditions of use or labelling obligations.

2008/06/27
Committee: AGRI

Proposal for a regulation − amending act
Article 3 – paragraph 2 – point a

(a) "novel food" means~~: (i)~~ food that has not been used for human consumption to a significant degree within the Community before 15 May 1997;, including (i) food of plant or animal origin when a non-traditional breeding technique not used before 15 May 1997 is applied to the plant or animal; and (ii) food to which is applied a new production process, not used before 15 May 1997, 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. The use of a food exclusively as, or in, a food supplement shall not be sufficient to show ~~whether~~that it has been used for human consumption to a significant degree within the Community before 15 May 1997. However, if a food has been used exclusively as, or in, a food supplement prior that date, it can be placed on the Community market after that date for the same use without being considered as novel food. FBefore the date of application of this Regulation, further criteria for assessing ifwhether a food has been used for human consumption to a significant degree within the Community before 15 May 1997, which are designed to amend non- essential elements of this Regulation, inter alia by supplementing it, ~~may~~shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3). (ii) food of plant or animal origin when to the plant and animal is applied a non- traditional breeding technique not used before 15 May 1997; and (iii) food to which is applied a new production process, not used before 15 May 1997, 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.

2008/06/27
Committee: AGRI

Proposal for a regulation − amending act
Article 6 – point c a (new)

(ca) it is considered to be produced under ethically acceptable conditions.

2008/06/27
Committee: AGRI

Proposal for a regulation − amending act
Article 8

Traditional food from a third country 1. A food business operator intending to place a traditional food from a third country on the market in the Community shall notify it to the Commission, indicating the name of the food, its composition and country of origin. The notification shall be accompanied by documented data demonstrating the history of safe food use in the third country. 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. 3. Within four months from the date on which the notification provided for in paragraph 2 is forwarded by the Commission, a Member State and 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. In that case, the food shall not be placed on the market in the Community and Articles 5 to 7 shall apply. The notification as referred to in paragraph 1 shall be considered as an application referred to in Article 3(1) of the Regulation XX/XXX [common procedure]. The Commission shall inform the food business operator concerned of the safety objections invoked accordingly within five months from the date of the notification in accordance with paragraph 1. 4. If no reasoned safety objections, based on scientific evidence, have been raised and no information thereof has been communicated to the food business operator concerned in accordance with paragraph 3, the traditional food may be placed on the market in the Community after five months from the date of the notification in accordance with paragraph 1. 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, after five months from the date of the notification in accordance with paragraph 1. 6. Detailed rules for the implementation of this Article, which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).Article 8 deleted

2008/06/27
Committee: AGRI

Proposal for a regulation − amending act
Article 10 a (new)

Article 10a Opinion of the European Group on Ethics in Science and New Technologies Where appropriate, on ethical questions relating to science and new technologies of major ethical importance, the Commission, on its own initiative or at the request of a Member State, may consult the European Group on Ethics and new Technologies with a view to obtaining its opinion on ethical issues. The Commission shall make this opinion publicly available, including by publishing it on a dedicated page of its website.

2008/06/27
Committee: AGRI

Proposal for a regulation
Recital 5

(5) The existing definition of novel food should be clarified and updated by replacing the existing categories, with a reference to the general definition of food 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 and an explanation of the criteria for novelty.

2008/10/16
Committee: ENVI

Proposal for a regulation
Recital 6

(6) The scope of this Regulation should include all foods, which have not been used for human consumption to a significant degree within the Community before 15 May 1997. The criteria for novelty of a food should include the use of new species of organisms like plants, animals, microorganisms, fungi or algae. Also the use of new parts of existing organisms and substances with a new molecular structure should be regarded as novel foods. An existing food should be considered as novel if it has been modified in a way that changes its chemical composition, molecular structure, particle size or other elements, which are likely to have an impact on food safety. It should also be clarified that a food should be considered as novel when it is applied a production technology, which was not previously used. In particular, emerging technologies in breeding and food production processes, which have an impact on food and thus might have an impact on food safety, should be covered by this Regulation. Novel food should therefore include foods derived from plants and animals, produced by non-traditional breeding techniques, and foods modified by new production processes, such as nanotechnology and nanoscience which might have an impact on food safety. Food derived from new plant varieties, or animal breeds produced by traditional breeding techniques, should not be considered as novel foods.

2008/10/16
Committee: ENVI

Proposal for a regulation
Recital 7

(7) I~~f necessary, i~~mplementing measures should be adopted to provide for further criteria in order to facilitate the assessment of whether a food has been used for human consumption to a significant degree within the Community before 15 May 1997. If a food has been used exclusively as or in a food supplement, as defined in Directive 2002/46/EC, prior that date, it can be placed on the market after that date for the same use without being considered as a novel food. However, that use as or in a food supplement should not be taken into account for the assessment whether it has been used for human consumption to a significant degree within the Community before 15 May 1997. Therefore, other uses of the food concerned, e.g. other than food supplement uses, have to be authorised in accordance with this Regulation.

2008/10/16
Committee: ENVI

Proposal for a regulation
Recital 8 a (new)

(8a) The provisions of Directive 2001/83/EC on the Community code relating to medicinal products for human use1 should apply where, taking into account all its characteristics, a product may fall within the definition of ‘medicinal product’ and within the definition of a product covered by other Community legislation. In this respect, a Member State may, if it establishes in accordance with Directive 2001/83/EC that a substance is a medicinal product, restrict the placing on the market of such product in accordance with Community law. 1 OJ L 311, 28.11.2001, p.67.

2008/10/16
Committee: ENVI

Proposal for a regulation
Recital 10

(10) Foods which are intended for technological uses or which are genetically modified should not fall within the scope of this Regulation as long as these foods are covered by a safety evaluation and approval according to other Community legislations. Therefore, food used solely as additives falling within the scope of Regulation (EC) No XX/XXX of the European Parliament and of the Council of [..], flavourings falling within the scope of Regulation (EC) No XX/XXX of the European Parliament and of the Council of [..], extraction solvents falling within the scope of Council Directive 88/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients, enzymes falling within the scope of Regulation (EC) No XX/XXX of the European Parliament and of the Council of [..] and genetically modified food falling within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed should be excluded from the scope of this Regulation.

2008/10/16
Committee: ENVI

Proposal for a regulation
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, which may include information relating to ethical considerations. Therefore, the inclusion of a novel food in the Community list may impose specific conditions of use or labelling obligations.

2008/10/16
Committee: ENVI

Proposal for a regulation
Article 2 – paragraph 2 – point (a) (ii)

(ii) food flavourings falling within the scope of Regulation (EC) No [on food flavourings], except where the flavourings mentioned in Article 8.1 (a), (b) and (c) of the Regulation on food flavourings are produced from a novel food;

2008/10/16
Committee: ENVI

Proposal for a regulation
Article 2 – paragraph 2 – point (a) (v)

(v) vitamins and minerals falling within the scope of Directive 89/398/EEC, Directive 2002/46/EC or Regulation (EC) No 1925/2006, except where the vitamins or minerals are obtained from new sources or using a production process, which was not taken into account when they were authorised under the respective legislation.

2008/10/16
Committee: ENVI

Proposal for a regulation
Article 3 – paragraph 2 - point (a) (i))

(a) “novel food” means: ~~(i)~~ food, that has not been used for human consumption to a significant degree within the Community before 15 May 1997;, including

2008/10/16
Committee: ENVI

Proposal for a regulation
Article 3 – paragraph 2 - point (a) (i) – subparagraph

The use of a food exclusively as or in a food supplement shall not be sufficient to show whether it has been used for human consumption to a significant degree within the Community before 15 May 1997. However, if a food has been used exclusively as or in a food supplement prior that date, it can be placed on the Community market after that date for the same use without being considered as novel food. FBefore the date of application of this Regulation, further criteria for assessing if a food has been used for human consumption to a significant degree within the Community before 15 May 1997, which are designed to amend non- essential elements of this Regulation, inter alia by supplementing it, ~~may~~shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).

2008/10/16
Committee: ENVI

Proposal for a regulation
Article 6 – point (c a) (new)

(ca) it is considered to be produced under ethically acceptable conditions.

2008/10/16
Committee: ENVI

Proposal for a regulation
Article 8

1. A food business operator intending to place a traditional food from a third country on the market in the Community shall notify it to the Commission, indicating the name of the food, its composition and country of origin. The notification shall be accompanied by documented data demonstrating the history of safe food use in the third country. 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). 3. Within four months from the date on which the notification provided for in paragraph 2 is forwarded by the Commission, a Member State and 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. In that case, the food shall not be placed on the market in the Community and Articles 5 to 7 shall apply. The notification as referred to in paragraph 1 shall be considered as an application referred to in Article 3(1) of the Regulation XX/XXX [common procedure]. The Commission shall inform the food business operator concerned of the safety objections invoked accordingly within five months from the date of the notification in accordance with paragraph 1. If no reasoned safety objections, based on scientific evidence, have been raised and no information thereof has been communicated to the food business operator concerned in accordance with paragraph 3, the traditional food may be placed on the market in the Community after five months from the date of the notification in accordance with paragraph 1. 5. The Commission shall, in accordance with paragraph 4, publish a list of traditional foods from third countries. that may be placed on the market in the Community. 6. Detailed rules for the implementation of this Article, which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).deleted

2008/10/16
Committee: ENVI

Proposal for a regulation
Article 11 a (new)

Article 11a European Group on Ethics and new Technologies Where appropriate, on ethical questions relating to science and new technologies of major ethical importance, the Commission, on its own initiative or at the request of a Member State, may consult the European Group on Ethics and new Technologies, with a view to obtaining its opinion on ethical issues. The Commission shall make this opinion available to the public.

2008/10/16
Committee: ENVI