94 Amendments of Alessandro FOGLIETTA

Proposal for a directive
Recital 7

(7) This Directive should also cover embryonic and foetal forms of vertebrate animals, asin cases where there is scientific evidence showing that such forms in the last third of their development have an increased risk of experiencing pain, suffering and distress, which may also affect negatively their subsequent development. Scientific evidence has also shown that procedures on mammal embryonic and foetal forms at an earlier stage of development could result in pain, suffering, distress or lasting harm, should the developmental forms be allowed to live beyond the first two thirds of their development.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Recital 16

(16) With current scientific knowledge the use of non-human primates in scientific procedures is still necessary in biomedical research. Due to their genetic proximity to human beings and to their highly developed social skills, the use of non- human primates in scientific procedures raises specific ethical and practical problems in terms of meeting their behavioural, environmental and social needs in a laboratory environment. ~~Furthermore, the use of non-human primates is of the highest concern to the public.~~ Therefore the use of non-human primates should only be allowed in those essential biomedical areas for the benefit of human beings for which no other replacement alternative methods are yet available and only in cases where the procedures are carried out in relation to clinical conditions having a substantial impact on patients’ day-to-day functioning as being either life- threatening or debilitating, or for the preservation of the respective non- human primate species. Fundamental research in some areas of the biomedical sciences can provide important new information relevant to many life-threatening and debilitating human conditions. The reference to life-threatening or debilitating clinical conditions is established terminology in EC legislation as reflected in Regulation 141/2000/EC, in Directive 2001/20/EC, Regulation 726/2004/EC and Commission Regulation 507/2006/ECabout human beings.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Recital 18

(18) The capture of non-human primates from the wild is highly stressful for the animals and increases the risk of injury and suffering during capture and transport. In order to gradually end the capturing of animals from the wild for breeding purposes, only animals that are the offspring of an animal which has been bred in captivity should be made available for use in scientific procedures as soon as possible. Establishments breeding and supplying non-human primates in the European Union should therefore have a strategy in place to support and facilitate the progressive ~~move towards that goal~~development of self- sufficient colonies.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Recital 40

(40) To ensure that the public is informed, it is important that objective information on the projects using live animals is made publicly available. The format of that information should not violate proprietary rights or expose confidential information. Therefore, user establishments should provide anonymous non-technical summaries of those projects~~, including the results of any retrospective assessments,~~ and make those summaries publicly available.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 2 – paragraph 2 – point a

(a) live non-human vertebrate animals, including independently feeding larval forms and embryonic or foetal forms as from the last third of their normal development except for hens' eggs used for vaccine production and quality control;

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 5 – paragraph 2 – point a

(a) the avoidance, prevention, diagnosis or treatment (including the development of medical devices) of disease, ill-health or other abnormality or their effects in human beings, animals or plants;

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 8 – paragraph 1 – point a

(a) the procedure has one of the purposes referred to in points (1), (2)(a), (3) and ~~is undertaken with a view to the avoidance, prevention, diagnosis or treatment of life- threatening or debilitating clinical conditions in human beings or the purpose referred to in point~~ (5) of Article 5;

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 8 – paragraph 2

2. Notwithstanding paragraph 1, g~~reat apes shall not be used in procedures, subject to the use of the safeguard clause in Article 50.~~ iven their particularly high level of neurophysiological sensitivity and cognitive development, procedures may be carried out on great apes only with a view to the avoidance, prevention, diagnosis or treatment of clinical conditions that are life-threatening for human beings or these animal species or which cause serious suffering and impairment or which threaten the survival of the species. In order to ensure that procedures are carried out on great apes only in exceptional cases, every corresponding project proposal must comply with the strictest possible conditions and undergo the most stringent possible scrutiny.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 10 – paragraph 1 – subparagraph 2

~~However~~Where possible, as from the dates set out in Annex III, Member States shall ensure that non-human primates listed in that Annex may only be used in procedures where they are the offspring of ~~non-human primates which have been bred~~ self-sustaining c~~aptivity~~olonies.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 10 – paragraph 2 a (new)

2a. The Commission shall assess the welfare of the animals and the appropriateness of implementing the measures called for in paragraph 1 five years from the entry into force of this directive.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 15 – paragraph 2

2. Member States shall ensure that the procedures classified as "severe" are not performed if the pain, suffering or distress is likely to be prolonged unless there are any factors justifying the use of such procedures.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 16 – paragraph 1 – introductory phrase

1. Member States shall ensure that an animal already used in a procedure, when a different animal on which no procedure has previously been carried out could also be used, may be subsequently re-used in a new unrelated procedure only when all of the following conditions are met:

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 16 – paragraph 1 – point a

(a) the previous procedure was classified as 'up to m~~ild~~oderate';

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 16 – paragraph 1 – point c

(c) the further procedure is classified as 'up to m~~ild~~oderate' or 'non-recovery'. The repeated use of animals shall be accompanied by veterinary examinations.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 16 – paragraph 1 – point c a (new)

(ca) a prior veterinary inspection is made before the possible re-use.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 16 – paragraph 2

2. By way of derogation from paragraph 1, the competent authority, on the basis of scientific justification, may allow re-use of an animal ~~as long as the animal is not used more than once after having undergone a procedure entailing severe pain, distress or equivalent suffering and the further~~if the previous procedures used on the same animal are classified as 'moderate' and the subsequent procedure iss are classified as 'up to m~~ild~~oderate' or as 'non-recovery'.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 27 – paragraph 1

1. Member States shall ensure that EU breeding and supplying establishments of non-human primates have a strategy in place for increasing the proportion of animals that are the offspring of non- human primates that have been bred in captivity.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 27 – paragraph 2

2. Establishments acquiring non-human primates shall supply proof to the competent authority, on request, that the establishment from which animals have been acquired have a breeding strategy in place.deleted

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 30 – paragraph 1 – introductory sentence

1. Member States shall ensure that all breeding, supplying and user establishments keep, where possible, the following information on each dog, cat and non- human primate:

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 35 – paragraph 1

1. Member States shall ensure that projects classified as 'severe' or any projects involving non-human primates are not carried out without a prior authorisation by the competent authority. All other projects shall be notified to the competent authority.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 35 – paragraph 2

2. ~~Granting of authorisation~~The commencement of the project shall be subject to favourable ethical evaluation by the competent authority.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 35 – paragraph 2 a (new)

2a. Projects required by law shall not need formal approval, provided that they do not involve 'severe' procedures or the use of non-human primates but are subject to favourable ethical evaluation. Or. it

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 36 – paragraph 2

2. Member States may waive the requirement in paragraph 1(b) and permit the user establishment to submit a reduced project proposal covering only the information required for the ethical evaluation and elements listed in Article 41(2), provided that the project involves only procedures classified as "'up to mild"' or 'moderate' and does not use non-human primates.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 37 – paragraph 4

4. Ethical evaluation shall be performed in a transparent manner, by integrating the opinion of independent parties whilst respecting information confidentiality and intellectual property rights.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 38 – paragraph 4

4. Without prejudice to paragraph 3, all projects involving only procedures classified as "'up to mild"' or 'moderate' shall be exempted from the requirement for a retrospective assessment.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 40 – paragraph 1 – introductory sentence

1. Subject to safeguarding confidential information, company and personnel details, the non-technical project summary shall provide the following:

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 40 – paragraph 1 – point b

b) a demonstration ~~of compliance with the requirement~~that the principles of replacement, reduction and refinement have been considered.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 41 – paragraph 4

4. 4. Member States ~~may~~shall allow the authorisation of multiple projects when those projects ~~are required by law~~involve standardised procedures which have been approved further to an ethical opinion.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 42 – paragraph 1

1. The competent authority may amend or renew the project authorisation on the request of the user establishment. Amendments which do not affect animal welfare may be adopted by means of the ethical opinion procedure.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 42 – paragraph 2

2. Any ~~amendment or~~ renewal of a project authorisation shall be subject to a further favourable ethical evaluation.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 42, paragraph 2 a (new)

2a. Amendments to 'mild or moderate' procedures which do not determine an increase in severity of those procedures shall be notified to the competent authority further to approval by the Ethics Committee.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 42 – paragraph 5 a (new)

5a. Each amendment to 'severe' procedures, or to procedures which determine an increase in severity, is subject to a further favourable ethical evaluation and approval by the competent authority.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 43 – paragraph 1

1. Member States shall ensure that the decision to grant an authorisation is taken and communicated to the user establishment at the latest within 30 days from the submission of the application. Should the Member State fail to take a decision within that period, the authorisation shall be deemed to have been granted~~, where the project concerned involves only procedures classified as "up to mild" and non-human primates are not used. In all other cases, no such presumption shall apply~~.

2009/03/16
Committee: AGRI

2008/0211(COD)

Proposal for a directive
Article 43 – paragraph 2

2. ~~Notwithstanding~~Subject to the provisions of paragraph 1, in exceptional circumstances and where the project is non-routine, multi-disciplinary and innovative, the decision to grant an authorisation shall be taken and communicated to the user establishment within 60 days from the submission of the application.

2009/03/16
Committee: AGRI

2008/0151(COD)

Proposal for a directive
Recital 2

(2) The disparities between the laws or administrative measures adopted by the Member States in relation to the ecodesign of ~~energy related~~ products can create barriers to trade and distort competition in the Community and may thus have a direct impact on the establishment and functioning of the internal market. The harmonisation of national laws is the only means to prevent such barriers to trade and unfair competition. The extension of the scope to all energy -related products ensures that ecodesign requirements for all ~~significant energy related produ~~products having a significant environmental impact and presenting a significant potential for improvement of their environmental impacts can be harmonised at Community level. The extension to energy-related products should be applied insofar it does not impose a disproportionate economic burden which may undermine the competitiveness of SMEs within the internal market.

2009/02/03
Committee: ENVI

2008/0151(COD)

Proposal for a directive
Recital 2 a (new)

(2a) This Directive should apply only insofar as there are no specific provisions with a similar objective, nature or effect in other Community harmonisation legislation. Confusion in the market and excessive costs due to overlapping legislation must carefully be avoided.

2009/02/03
Committee: ENVI

2008/0151(COD)

Proposal for a directive
Article 1 - paragraph 1 a (new)

1a. Insofar as existing legislation covers part or all of the requirements of this Directive, priority shall be given to the existing regulatory framework.

2009/02/03
Committee: ENVI

2008/0151(COD)

Antonio MUSSA, Alessandro FOGLIETTA, Salvatore TATARELLA, Cristiana MUSCARDINI, Roberta ANGELILLI

Proposal for a directive
Article 1 - paragraph 1 b (new)

1b. Custom made products are exempt from the scope of this Directive.

2009/02/03
Committee: ENVI

2008/0142(COD)

Proposal for a directive
Recital 5

(5) As confirmed by the Court of Justice on several occasions, while recognizing their specific nature, all types of medical care fall within the scope of the Treaty. In particular, all European citizens holding a European Health Insurance Card should, by virtue of the principles of solidarity and reciprocity, be given emergency care in whichever Member State a patient happens to be, irrespective of the financial implications that the treatment might entail for the hospital providing the service or of the country or local authority responsible for that hospital. In accordance with the principle of reciprocity, the services should be paid for by the Member State where the emergency treatment was administered, and the cost, subsequently reimbursed in full by the Member State of affiliation.

2009/01/21
Committee: ENVI

2008/0142(COD)

Antonio MUSSA, Alessandro FOGLIETTA, Salvatore TATARELLA, Cristiana MUSCARDINI, Roberta ANGELILLI

Proposal for a directive
Recital 10

(10) For the purposes of this Directive, the concept of “cross-border healthcare” covers the following modes of supply of healthcare: – Use of healthcare abroad (i.e.: a patient moving to a healthcare provider in another Member State for treatment); this is what is referred to as ‘patient mobility’; – Cross-border provision of healthcare (i.e.: delivery of service from the territory of one Member State into the territory of another); such as telemedicine services, remote diagnosis and prescription, laboratory services; – Provision of emergency healthcare and, subject to different rules, the delivery of care to patients who have chosen to go to another Member State (the “Member State of delivery”) in order to undergo planned treatment; – Permanent presence of a healthcare provider (i.e.: establishment of a healthcare provider in another Member State); and, – Temporary presence of persons (i.e.: mobility of health professionals, for example moving temporarily to the Member State of the patient to provide services).

2009/01/21
Committee: ENVI

2008/0142(COD)

Antonio MUSSA, Alessandro FOGLIETTA, Salvatore TATARELLA, Cristiana MUSCARDINI

Proposal for a directive
Recital 11

(11) As recognised by the Member States in the Council Conclusions on Common values and principles in European Union Health Systems there is a set of operating principles that are shared by health systems throughout the Community. These operating principles include quality, safety, care that is based on evidence and ethics, patient involvement, redress, the fundamental right to privacy with respect to the processing of personal data, and confidentiality. Patients, professionals and authorities responsible for health systems must be able to rely on these shared principles being respected and structures provided for their implementation throughout the Community. It is therefore appropriate to require that it is the authorities of the Member State on whose territory the healthcare is provided, who are responsible for ensuring compliance with those operating principles and, in any event, for delivering the healthcare needed to administer treatment in case of emergency. This is necessary to ensure the confidence of patients in cross-border healthcare, which is itself necessary for achieving patients’ mobility and free movement of provision of healthcare in the internal market as well as a high level of health protection.

2009/01/21
Committee: ENVI

2008/0142(COD)

Antonio MUSSA, Alessandro FOGLIETTA, Salvatore TATARELLA, Cristiana MUSCARDINI

Proposal for a directive
Recital 16

(16) Member States should ensure, that mechanisms for the protection of patients and the compensation for harm are in place for healthcare provided on their territory and that they are appropriate to the nature and extent of the risk. However, it is for the Member State to determine the nature and/or modalities of such a mechanism. Specific provisions and special coordinating measures should, in any event, be laid down in order to coordinate the activities of hospitals constituting centres of excellence, in particular with a view to guaranteeing access to the best care for those patients in the EU genuinely in need of it. To that end, and especially where patients acting by choice are concerned, each Member State should designate the national, regional, and local bodies responsible for ascertaining whether there is a real need to use healthcare in another Member State and for compiling lists of prior authorisations for treatment at a centre of excellence in a Member State other than the patient’s country of residence. The Member State of affiliation should thereafter provide the funds required to reimburse the cost of the treatment for which prior authorisation was obtained.

2009/01/21
Committee: ENVI

2008/0142(COD)

Antonio MUSSA, Alessandro FOGLIETTA, Salvatore TATARELLA, Cristiana MUSCARDINI, Roberta ANGELILLI

Proposal for a directive
Article 4 - points (f a) and (f b) (new)

fa ) "urgent acute patient" means a patient in a situation of health emergency, in particular one at risk of loss of life or loss of functioning of vital organs in the very near future, the treatment of whom requires beyond all doubt the immediate intervention of the health services; fb) "voluntary patient" means a patient choosing the place of treatment on the basis of a range of reasons such as: better treatment, shorter waiting periods, family reasons or convenience for convalescence.

2009/02/02
Committee: ENVI

2008/0142(COD)

Antonio MUSSA, Alessandro FOGLIETTA, Salvatore TATARELLA, Cristiana MUSCARDINI, Roberta ANGELILLI

Proposal for a directive
Article 8 – paragraph 2 a (new)

2a. A Member State may not refuse to provide care and must meet the full cost of treatment for any patient in an emergency situation on its territory.

2009/01/22
Committee: ENVI

2008/0142(COD)

Antonio MUSSA, Alessandro FOGLIETTA, Salvatore TATARELLA, Cristiana MUSCARDINI, Roberta ANGELILLI

Proposal for a directive
Article 8 a (new)

Article 8a Specialised care in hospitals constituting centres of excellence 1. The Commission and the Member States shall encourage hospitals constituting centres of excellence to coordinate their activities, not least with a view to establishing a data bank for patients giving information about the availability of treatment in such hospitals, and shall help to set up the networks necessary for professional interchange, exchange of information, rotating use of technologically advanced devices, and exchange of good practice regarding the treatment of patients. 2. Member States shall designate the national bodies called upon to assess the characteristics of patients’ diseases and the need for specialised care and to compile prior authorisation lists for the purposes of treatment in centres of excellence in a Member State other than the patient’s country of residence. National bodies shall work in close coordination with such regional and local counterparts as might exist. The home Member State of the centre concerned shall thereafter provide the funds necessary to pay for the treatment for which prior authorisation has been obtained.

2009/01/22
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, Guido SACCONI, Chris DAVIES, Alessandro FOGLIETTA, Elisabetta GARDINI

Proposal for a regulation
Recital 29

(29) The indication of the country of origin or of the place of provenance of a food should be provided whenever its absence is likely to mislead consumers as to the true country of origin or place of provenance of that product. In other cases, the provision of the indication of country of origin or place of provenance is left to the appreciation of food business operatorsagricultural raw material used in the product should be provided in the most suitable way, with a view to guaranteeing complete transparency and traceability. In all cases, the indication of country of origin or place of provenance should be provided in a manner which does not deceive the consumer and on the basis of clearly defined criteria which ensure a level playing field for the industry and improve consumers’ understanding of the information related to the country of origin or place of provenance of a food. Such criteria should not apply to indications related to the name or address of the food business operator.

2009/01/28
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, Guido SACCONI, Alessandro FOGLIETTA

Proposal for a regulation
Recital 41

(41) Member States should retain the right, depending on local practical conditions and circumstances, to lay down rules in respect of the provision of information concerning non-prepacked foods. Although in such cases the consumer demand for other information is limited, information on potential allergens is considered very important. Evidence suggests that most food allergy incidents can be traced back to non-prepacked food. Therefore such information should always be provided to the consumer.

2009/01/28
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, Guido SACCONI, Chris DAVIES, Alessandro FOGLIETTA, Elisabetta GARDINI

Proposal for a regulation
Article 2 – paragraph 2 – point g

(g) ‘place of provenance’ means any place where a food is indicated to come from, and that is not the ‘country of origin’ ~~as determined in accordance with Articles 23 to 26 of Council Regulation (EEC) No 2913/92~~;

2009/01/28
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, Guido SACCONI, Chris DAVIES, Alessandro FOGLIETTA, Elisabetta GARDINI

Proposal for a regulation
Article 2 – paragraph 2 – point g a (new)

(ga) ‘country of origin’ means the place of origin of the main agricultural raw material used in the preparation of the product.

2009/01/28
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, Chris DAVIES, Guido SACCONI, Alessandro FOGLIETTA

Proposal for a regulation
Article 2 – paragraph 2 – point t a (new)

(ta) ‘Processing’ means the process whereby one (or more) agricultural raw material(s) is (are) transformed into a finished product.

2009/01/28
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, John BOWIS, Guido SACCONI, Alessandro FOGLIETTA

Proposal for a regulation
Article 9 – paragraph 1 – point h

(h) tThe name or business name ~~and~~or a registered trademark and the address of the manufacturer, orf the packager and, for products coming from third countries, of a seller established within the Community;.

2009/01/28
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, John BOWIS, Guido SACCONI, Chris DAVIES, Alessandro FOGLIETTA, Elisabetta GARDINI

Proposal for a regulation
Article 9 – paragraph 1 – point i

(i) the country of origin or place of provenance where failure to indicate this might mislead the consumer to a material degree as to the true country of origin or place of provenance of the food, in particular if the information accompanying the food or the label as a whole would otherwise imply that the food has a different country of origin or place of provenance; in such cases tf unprocessed agricultural products and, for processed products, the area of cultivation or rearing of the main agricultural raw material used in the processing. The indication shall be in accordance with the rules laid down in Article 35(3) and (4) and those established in accordance with Article 35(5);

2009/01/28
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, Alessandro FOGLIETTA, Guido SACCONI

Proposal for a regulation
Article 14 - paragraph 1

1. Without prejudice to specific Community legislation applicable to particular foods as regards to the requirements referred to in Article 9(1)(a) to (k), when appearing on the package or on the label attached thereto, the mandatory particulars listed in Article 9(1) shall be pr~~inted on the package or on the label in characters of a font size of at least 3mm and shall be presented in a way so as to ensure a significant contrast between the print and background~~esented in a way so as to ensure legibility.

2009/01/23
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, Alessandro FOGLIETTA, Guido SACCONI

Proposal for a regulation
Article 14 - paragraph 1 - point (a) (new)

(a) For particular foods with mandatory labelling requirements provided for in specific Community legislation in addition to those particulars referred to in article 9(1), the font size should be such that it accommodates the need of the consumer for legibility of the additional information related to the particular use of those foods.

2009/01/23
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, Alessandro FOGLIETTA, Guido SACCONI

Proposal for a regulation
Article 29 – paragraph 1 – subparagraph 1 – point b

(b) the amounts of ~~fat, saturates~~protein, carbohydrates ~~with specific reference to sugars,~~ and ~~sal~~fat.

2009/01/23
Committee: ENVI

2008/0028(COD)

Proposal for a regulation
Article 34 - paragraph 1 a (new)

1a. Paragraph 1 shall not apply to foods defined in Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses and specific directives as referred to in Article 4(1) of that Directive.

2009/02/24
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, Alessandro FOGLIETTA, Chris DAVIES, Elisabetta GARDINI, Guido SACCONI

Proposal for a regulation
Chapter V - Title

~~Voluntary food information~~Chapter V Chapter V Mandatory origin labelling

2009/02/24
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, Alessandro FOGLIETTA, Chris DAVIES, Elisabetta GARDINI, Guido SACCONI

Proposal for a regulation
Article 35 - paragraph 2

2. Without prejudice to labelling in accordance with specific Community legislation, paragraphs 3 and 4 shall apply where indication of the country of origin or the place of provenance of a food is ~~voluntarily indicated~~mandatory to inform consumers that a food originates or comes from the European Community or a given country or place.

2009/02/24
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, Guido SACCONI, Chris DAVIES, Alessandro FOGLIETTA, Elisabetta GARDINI

Proposal for a regulation
Article 38 – paragraph 2

2. By means of paragraph 1, Member States may introduce measures concerning the mandatory indication of the country of origin or place of provenance of foods only where there is a proven link between certain qualities of the food and its origin or provenance. When notifying such measures to the Commission, Member States shall provide evidence that the majority of consumers attach significant value to the provision of this information.deleted

2009/02/24
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, Guido SACCONI, Alessandro FOGLIETTA

Proposal for a regulation
Article 41

1. Where foods are offered for sale to the final consumer or to mass caterers without prepackaging, or where ~~foods~~ are packed on the sales premises at the consumer'’s request or prepacked for direct sale, the Member States may adopt detailed rules concerning the manner in which the particulars specified in Articles 9 and 10 are to be shown. 2. Member States may decide not to require the provision of some of the particulars referred to in paragraph 1, other than those referred to in Article 9(1) (c), provided that the consumer or mass caterer still receives sufficient information, that they may require, have to be provided. 32. Member States shall communicate to the Commission the text of the measures referred to in paragraphs 1 ~~and 2 without delay~~.

2009/02/24
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, Guido SACCONI, Alessandro FOGLIETTA

Proposal for a regulation
Annex III – point 2.1

~~2.1 Foods ‘with containing a sweetener or sweeteners authorised pursu~~deleted sweetener(s)’ this statement shall accompanty t~~o Directive 89/107/ EEC~~he name of the food.

2009/03/02
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, Guido SACCONI, Alessandro FOGLIETTA

Proposal for a regulation
Annex III – point 2.2

~~2.2 Foods ‘with sugar(s) containing both an added sugar or sugars~~deleted and a sweetener ~~or sweeteners authorised pursuant to Directive 89/107/ EEC~~(s)’ this statement shall accompany the name of the food.

2009/03/02
Committee: ENVI

2008/0028(COD)

Amalia SARTORI, Françoise GROSSETÊTE, Guido SACCONI, Alessandro FOGLIETTA

Proposal for a regulation
Annex XI – part A – paragraph 2

As a rule, 15 % of ~~the recommended allowance specified in point 1 supplied by 100~~ RDA per 100g or serving for solids or 7,5% of RDA per 100ml or serving for ~~100 ml or per package if the package contains only a single portion should be taken into consideration in deciding what constitutes a significant amount~~liquids or 5% of RDA per 100kcal (12% of RDA 1 MJ), or an amount provided for by derogations granted according to Article 6 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods.

2009/03/02
Committee: ENVI

2008/0018(COD)

Proposal for a directive
Recital 16 a (new)

(16a) In order to avoid any possible duplication of evaluation under this Directive and Regulation (EC) No 1907/2006 concerning REACH, CMRs that have been evaluated and have not been prohibited under this Directive should not be made subject to proposals for restriction under Regulation (EC) No 1907/2006 on the grounds of risks to human health and should not be made subject to authorisation under Regulation (EC) No 1907/2006 on the grounds of risks to human health according to Article 58(2) of that Regulation. In order to avoid similar duplication, CMRs which have been evaluated for use in toys and which have not been prohibited under Regulation (EC) No 1907/2006 should not be made subject to restrictions or evaluation under this Directive.

2008/09/19
Committee: ITRE

2008/0018(COD)

Proposal for a directive
Recital 16 b (new)

(16b) It is necessary to apply a harmonised transition period of two years after the entry into force of this Directive for compliance with its provisions and a further transition period of one year after the entry into force of the revised Toy Standard EN 71-3 concerning the new chemical requirements of this Directive, to allow toy manufacturers and economic operators sufficient time to adapt to the new technical requirements and to ensure consistent application of this Directive throughout the European Union.

2008/09/19
Committee: ITRE

2008/0018(COD)

Proposal for a directive
Recital 32

(32) In particular power should be conferred on the Commission in order to adapt the chemical requirements in certain well defined cases ~~and grant exemptions from the prohibition of CMR substances in certain cases~~ as well as to adapt the wording of the specific warnings for certain categories of toys. Since those measures are of general scope and are designed to amend non-essential elements of this Directive and/or to supplement this Directive by the addition of new non- essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

2008/09/19
Committee: ITRE

2008/0018(COD)

Proposal for a directive
Article 52

Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or ~~at the latest 2 years after this Directive entered into force.~~ for two years after this Directive enters into force. With regard to Articles 3(1) and 9(1) and part III of Annex II on chemical properties, Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market either before this Directive entered into force or within the period of one year following the entry into force of the revised Toy Standard EN 71-3 on the new chemical requirements of this Directive.

2008/09/19
Committee: ITRE

2008/0018(COD)

Proposal for a directive
Annex II – part III – paragraph 3

3. Without prejudice to the application of the restrictions under the first sentence of point 2, t~~he use in toys of~~oys shall not contain substances that are classified as carcinogenic, mutagenic or toxic for reproduction ~~(CMR)~~categories 1 or 2 according to Annex I of Directive 67/548/EEC in individual concentrations equal to or greater than the relevant concentrations established for the classification of preparations containing the substances in accordance with the provisions of Directive 1999/45/EC ~~shall be prohibited,~~ except if the substances are contained in components o~~f toys or micro- structurally distinct parts of toys that are not accessible to any physical contact by children~~r parts of toys that are not accessible by children as defined in standard EN 71.

2008/09/19
Committee: ITRE

2008/0018(COD)

Proposal for a directive
Annex II – part III – paragraph 4

4. Substances ~~or preparations~~ classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC may be used in toys provided that the following two conditions are met:

2008/09/19
Committee: ITRE

2008/0018(COD)

Proposal for a directive
Annex II – part III – paragraph 4 – subparagraph 4.1

4.1 ~~use of the substance has bee~~the relevant Scientific Committee has concluded that the substances classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC contained in accessible components or parts of toys above the concentration limits in paragraph 3 does not pose an unacceptable risk to human health, in particular in relation to exposure. To that end, manufacturers may, prior to the end of the transition period in Article 52, apply to the Commission for an evaluatedion by the relevant Scientific Committee ~~and found to be safe,~~of the risk posed by substances classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC. That application shall be accompanied by relevant information in particular ion ~~view of exposure, and a Decision as referred to in Article 45(2) has been taken;~~exposure. Upon the receipt of an application, the Commission shall without delay mandate the Scientific Committee to provide its opinion. Manufacturers may continue to place on the market toys containing the substances classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC for which a request has been submitted and until a decision is adopted.

2008/09/19
Committee: ITRE

2008/0018(COD)

Proposal for a directive
Annex II – part III – paragraph 4 – subparagraph 4.2

~~4.2 there are no suitable substances available, as documented in an analysis of alternatives,~~deleted

2008/09/19
Committee: ITRE

2008/0018(COD)

Proposal for a directive
Annex II – part III – paragraph 5

5. ~~Substances~~Without prejudice to the application of the restrictions under the first sentence orf p~~reparations classified as CMR~~aragraph 2, toys shall not contain substances that are classified as carcinogenic, mutagenic or toxic for reproduction category 3 according to Annex I of Directive 67/548/EEC ~~may be~~if: (i) they have been prohibited for useds in ~~toys if use of the substance has been evaluated by the relevant Scientific Committee and found to be safe, in particular in view of exposure, and follow~~consumer articles under Regulation (EC) No 1907/2006 (REACH); or (ii) the CMR category 3 substance is contained in components or parts of toys that are accessible, as defined in standard EN71, by children and the relevant Scientific Committee has evaluated ing a ~~Decision as referred to in Article 45(2) and provided that they are not prohibited for u~~ccordance with Article 45(2) that the content of the substance in the toy poses ian ~~consumer articles under Regulation (EC) No 1907/2006 (REACH).~~ unacceptable risk to human health, in particular in relation to exposure.

2008/09/19
Committee: ITRE

2008/0018(COD)

Proposal for a directive
Recital 16 a (new)

~~Any duplication of evaluation by different EU bodies for the use of the same substance in toys must be avoided. Once a substance is evaluated where it is contained in toys~~(16a) In order to avoid any possible duplication of evaluation under this Directive and Regulation (EC) No 1907/2006 (REACH), CMRs that have been evaluated and have not been prohibited under this Directive~~, it~~ should not ~~subsequently become subject to restrictions or to the Authorisation procedure under Reac~~be made subject to proposals for restriction under Regulation (EC) No 1907/2006 (REACH) on account of risks to human health and should not be made subject to authorisation under Regulation (EC) No 1907/2006 (REACH) on account of risks to human health in accordance with (Article 58(2) ~~of Reach). Similarly, if a substance is not prohibited under REACH~~thereof. In order to avoid similar duplication, CMRs which have been evaluated for use in a toy ~~subsequent to a relevant evaluation, it should not be made subject to the provisions of this Directive~~s and which have not been prohibited under Regulation (EC) No 1907/2006 (REACH) should not be made subject to restrictions or evaluation under this Directive. Or. en Justification.

2008/09/11
Committee: IMCO

2008/0018(COD)

Proposal for a directive
Article 10 – paragraph 2 – subparagraph 1

2. 2. The ~~manufacturer shall mark the warnings in a visible, clearly legible and accurate manner on the toy, on an affixed label~~warnings shall be formulated in an accurate, visible, clearly and easily legible comprehensible manner for users or those looking after them and affixed to the toy or, should that be technically impossible, on a label affixed to the toy or on the packaging and, if appropriate, on the instructions for use which accompany the toy. Small toys that are sold without packaging shall have appropriate warnings affixed to them. .

2008/07/25
Committee: ENVI

2008/0018(COD)

Proposal for a directive
Article 10 – paragraph 2 – subparagraph 2

Warnings specifying the minimum and maximum ages for users shall be visible, ~~legibl~~clearly and easily legible and accurate and conspicuously displayed at the point of sale. The authorised representatives, importers and distributors must be notified of these warnings so that warnings specifying the minimum and maximum ages for users may be correctly affixed at the point of sale.

2008/07/25
Committee: ENVI

2008/0018(COD)

Proposal for a directive
Article 10 – paragraph 2 – subparagraph 2 a (new)

Warnings must alternate so that they appear regularly. Warnings shall be printed on the most visible surface of the unit packet and on all external packaging, with the exception of transparent packaging, used for the retail sale of the toy in question.

2008/07/25
Committee: ENVI

2008/0018(COD)

Proposal for a directive
Recital 16 b (new)

(16b) It is necessary to apply a harmonized transition period of two years after the entry into force of this Directive for compliance with its provisions and a further transition period of one year after the revised Toy Standard EN 71-3 on the new chemical requirements of this Directive has entered into force to provide toy manufacturers and economic operators with sufficient time to adapt to the new technical requirements and to ensure consistent application of this Directive throughout the EU.

2008/09/11
Committee: IMCO

2008/0018(COD)

Proposal for a directive
Article 10 – paragraph 2 –subparagraph 2 b (new)

Member States may determine the location of the warnings to appear on the surfaces in question in the light of linguistic requirements.

2008/07/25
Committee: ENVI

2008/0018(COD)

Proposal for a directive
Recital 32

(32) In particular power should be conferred on the Commission ~~in order~~ to adapt the chemical requirements in certain well defined cases ~~and grant exemptions from the prohibition of CMR substances in certain cases~~ as well as to adapt the wording of the specific warnings for certain categories of toys. Since those measures are of general scope and are designed to amend non-essential elements of this Directive ~~and/or to supplement this Directive by the addition of~~, inter alia by supplementing it with new non- essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

2008/09/11
Committee: IMCO

2008/0018(COD)

Proposal for a directive
Article 52

Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or ~~at the latest 2 years after~~during a period of 2 years after this Directive enters into force. With regard to Article 3(1), Article 9(1) and point III of Annex II, Member States shall not impede the placing on the market of toys in accordance with Directive 88/378/EEC which were placed on the market before this Directive entered into force or 1 year after the revised Toy Standard EN 71-3 on the new chemical requirements of this Directive entered into force.

2008/09/11
Committee: IMCO

2008/0018(COD)

Proposal for a directive
Annex II – Part III – point 3

3. Without prejudice to the application of the restrictions under the first sentence of point 2, t~~he use in toys of~~oys shall not contain substances that are classified as carcinogenic, mutagenic or toxic for reproduction ~~(CMR)~~categories 1 or 2 according to Annex I of Directive 67/548/EEC in individual concentrations equal to or greater than the relevant concentrations established for the classification of preparations containing the substances in accordance with the provisions of Directive 1999/45/EC ~~shall be prohibited,~~ except if the substances are contained in components o~~f toys or micro- structurally distinct parts of toys that are not accessible to any physical contact by children~~r parts of toys that are not accessible by children as defined in standard EN 71.

2008/09/11
Committee: IMCO

2008/0018(COD)

Proposal for a directive
Annex II – Part III – point 4

4. Substances ~~or preparations~~ classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC may be used in toys provided that the following two conditions are met: 4.1 ~~use of the substance has been evaluated by the relevant Scientific Committee and found to be safe, in particular in view of exposure, and a Dec~~The relevant Scientific Committee has evaluated that the substances classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC contained in accessible components or parts of toys above the concentration limits in point 3 does not pose an unacceptable risk to human health, in particular in view of exposure. To that end, manufacturers may submit requests to the Commission ~~as referred to in Article 45(2) has been taken; 4.2~~prior to the end of the transition period in Article 52 for an evaluation by the relevant Scientific Committee of the risk posed by substances classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC. That request shall be accompanied by relevant information in particular on exposure. Upon the receipt of a re ~~no suitable substances available, as documented in an analysis of alternatives, 4.3 t~~quest, the Commission shall without delay mandate the Scientific Committee to provide its opinion. Manufacturers may continue placing toys on the market containing the substances classified as CMR category 1 and 2 according to Annex I of Directive 67/548/EEC for which a request has been submitted and until a decision is adopted. A decision to amend Annex IIa listing the CMR 1 and 2 substances concerned by this Article shall be taken in accordance with Article 45(2). 4.2 They arhave not already been prohibited for uses in consumer articles under Regulation (EC) No 1907/2006 (REACH). The Commission shall mandate the relevant Scientific Committee to re- evaluate those substances ~~or preparations~~listed in Annex IIa as soon as safety concerns arise and at the latest every 5 years from the date that a decision in accordance with Article 45(2) was taken.

2008/09/11
Committee: IMCO

2008/0018(COD)

Proposal for a directive
Annex II – Part III – point 5

5. ~~Substances or preparations classified as CMR c~~Without prejudice to the application of the restrictions under the first sentence of point 2, toys shall not contain substances that are classified as carcinogenic, mutagenic or toxic for reproduction Category 3 according to Annex I of Directive 67/548/EEC ~~may be~~if: (i) they have been prohibited for useds in ~~toys if use of the substance has been evaluated by the relevant Scientific Committee and found to be safe~~consumer articles under Regulation (EC) No 1907/2006 (REACH); or (ii) the CMR 3 substance is contained in components or parts of toys that are accessible, as defined in standard EN71, by children and the relevant Scientific Committee has evaluated that the content of the substance in the toy poses an unacceptable risk to human health, in particular in view of exposure~~, and following a D~~. A decision asto re~~ferred to in Article 45(2) and provided that they are not prohibited for uses in consumer articles under Regulation (EC) No 1907/2006 (REACH~~vise Annex IIb listing the CMR 3 substances prohibited by this provision shall be taken in accordance with Article 45(2).

2008/09/11
Committee: IMCO

2008/0018(COD)

Proposal for a directive
Annex II a -title (new)

Annex IIa List of CMR 1 and 2 substances exempt from the prohibition of Annex II point III (3)

2008/09/11
Committee: IMCO

2008/0018(COD)