142 Amendments of Giulia MOI
Amendment 13 #
2016/2204(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
A a. whereas the FAO notes in its main publication "The State of Food and Agriculture" that women make significant contributions to the rural economy in all regions and their roles vary from one region to another, even though they always have less access than men to the resources and opportunities that they need to be more productive;
Amendment 42 #
2016/2204(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
E a. whereas we have a duty to sustain farming as a core activity performed by women in the areas where they live, in order to ensure that rural areas are dynamic and job-rich;
Amendment 46 #
2016/2204(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
F a. whereas, in many Member States, women in rural regions have limited access to employment in farming or elsewhere, yet they play an extremely important role in rural development and in the social fabric of rural areas;
Amendment 71 #
2016/2204(INI)
Motion for a resolution
Recital J a (new)
Recital J a (new)
J a. whereas increased access for young people and women to land, livestock farming, education, financial services, technology and rural jobs would improve generational renewal in farming and foster economic growth and social well-being;
Amendment 264 #
2016/2204(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Calls for sustainable strategies to maintain, encourage and support women's entrepreneurial initiatives, networks and women's organisations in agriculture and in rural areas through easier access to credit, promoting and improving education and vocational training;
Amendment 268 #
2016/2204(INI)
Motion for a resolution
Paragraph 8 b (new)
Paragraph 8 b (new)
8 b. Stresses the need to give young women farmers long-term prospects in order to address rural depopulation;
Amendment 269 #
2016/2204(INI)
Motion for a resolution
Paragraph 8 c (new)
Paragraph 8 c (new)
8 c. Calls on the Commission and the Member States to introduce initiatives to support entrepreneurship, emerging industries and the labour market in agriculture and forestry in order to create new and maintain existing agricultural jobs as well as to make them more attractive to young women;
Amendment 291 #
2016/2204(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9 a. Calls on the Commission and the Member States to undertake to encourage and facilitate women's access to the labour market in rural areas;
Amendment 31 #
2016/0230(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The Paris Agreement, inter alia, sets out a long-term goal in line with the objective to keep the global temperature increase well below 2°C above pre- industrial levels and to pursue efforts to keep it to 1.5°C above pre-industrial levels. In order to; to that end, the role of forests in achieveing this goal needs to be reiterated. Accordingly, the Parties should prepare, communicate and maintain successive nationally determined contributions. The Paris Agreement replaces the approach taken under the 1997 Kyoto Protocol which will not be continued beyond 2020. The Paris Agreement also calls for a balance between anthropogenic emissions by sources and removals by sinks of greenhouse gases in the second half of this century, and invites Parties to take action to conserve and enhance, as appropriate, sinks and reservoirs of greenhouse gases, including forests.
Amendment 113 #
2016/0230(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point e a (new)
Article 2 – paragraph 1 – point e a (new)
(ea) managed wetlands: land use reported as wetland remaining wetland, and settlement, other land converted to wetland and wetland converted to settlements and other lands
Amendment 114 #
2016/0230(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
Amendment 129 #
2016/0230(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
For the period from 2021 to 2025 and from 2026 to 2030, taking into account the flexibilities provided for in Article 11, each Member States shall ensure that at least emissions do not exceed removals, calculated as the sum of total emissions and removals on their territory in the land accounting categories referred to in Article 2 combined, as accounted in accordance with this Regulation, in line with Union long term commitments under the Paris Agreement.
Amendment 154 #
2016/0230(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Member States shall account for emissions and removals resulting from afforested land and deforested land, calculated as the total emissions and removals for each of the years in the periods from 2021 to 2025 and from 2026 to 2030 minus the value obtained by multiplying by five the Member State's average annual emissions and removals resulting from managed afforested land and deforested land, in its base period 2005-2007.
Amendment 158 #
2016/0230(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
Amendment 175 #
2016/0230(COD)
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
Amendment 180 #
2016/0230(COD)
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Member States that have chosen to include managed wetland in the scope of their commitments in accordance with Article 2 shall account for emissions and removals resulting from managed wetland, calculated as emissions and removals in the periods from 2021 to 2025 and/or from 2026 to 2030 minus the value obtained by multiplying by five the Member State’s average annual emissions and removals resulting from managed wetland in its base period 2005-2007.
Amendment 216 #
2016/0230(COD)
Proposal for a regulation
Article 8 – paragraph 3 – subparagraph 2
Article 8 – paragraph 3 – subparagraph 2
The national forestry accounting plan shall contain all the elements listed in Annex IV, section B and include a proposed new forest reference level based on the continuation of current forest management practice and intensity, as documented between 1990-2009 per forest type and per age class in national forests, expressed in tonnes of CO2 equivalent per year, assuming a constant ratio between solid and energy use of forest biomass.
Amendment 253 #
2016/0230(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. At the end of the periods from 2021 to 2025 and from 2026 to 2030, Member States may exclude from their accounts for afforested land and managed forest land greenhouse gas emissions resulting from natural disturbances exceeding the average emissions caused by natural disturbances in the period 2001-2020, excluding statistical outliers ('background level') calculated in accordance with this Article and Annex VI.
Amendment 267 #
2016/0230(COD)
Proposal for a regulation
Article 11 – paragraph 3
Article 11 – paragraph 3
3. To the extent that total removals exceed emissions in a Member State in the period from 2021 to 2025, and after subtraction of any quantity taken into account under Article 7 of Regulation [ ] on binding annual greenhouse gas emission reductions by Member States from 2021 to 2030 or transferred to another Member State pursuant to paragraph 2, that Member State may bank the remaining quantity to the period 2026-2030 up to limit of 5%.
Amendment 283 #
2016/0230(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
The Commission shall report to the European Parliament and to the Council by 28 February 2024 and every fivetwo years thereafter on the operation of this Regulation, its contribution to the EU's overall 2030 greenhouse gas emission reduction target and its contribution to the long-term goals of the Paris Agreement, and may make proposals if appropriate.
Amendment 301 #
2016/0230(COD)
Proposal for a regulation
Annex IV – part A – paragraph 1 – point c
Annex IV – part A – paragraph 1 – point c
(c) Reference levels should ensure a robust and credible accounting that excludes the impact of policies on the development of the forest sink, to guarantee that emissions and removals resulting from biomass use are properly accounted for;
Amendment 3 #
2015/2227(INI)
Motion for a resolution
Citation 3 a (new)
Citation 3 a (new)
– having regard to the UN's International Assessment of Agricultural Knowledge, Science and Technology for Development of the FAO, GEF, UNDP, UNEP, UNESCO, the World Bank and WHO,
Amendment 11 #
2015/2227(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the UN’'s Food and Agriculture Organisation (FAO) estimates that the expected rise in the world’'s population to 9.1 billion by 2050 will require a 60 % increase in food productionsupply and a 24 % increase in crop yields in the developed countries by that date; whereas the FAO also estimates that there will be only a 4.3 % increase in arable land by 2050; whereas between 30-50% of the food produced in the EU is wasted, and although it is difficult to measure and it occurs at varying rates according to sector and occurs at different stages of the production and supply chain in different parts of the world there is some consensus that the global average of food waste is around 30%;
Amendment 13 #
2015/2227(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas food sovereignty is a key element to allow the different regions of the world to produce the necessary agricultural products to feed themselves ; whereas it is the responsibility of the EU to improve its own agriculture by decreasing its own food resources footprint, e.g. by decreasing dependency on inputs like soya from deforested tropical forest, and by ceasing land grabbing and dumping on sensitive markets;
Amendment 16 #
2015/2227(INI)
Motion for a resolution
Recital A b (new)
Recital A b (new)
Ab. whereas land everywhere faces a drop-off in intrinsic productivity and fertility caused by land degradation, especially soil erosion, due to loss of ecosystem functions such as topsoil formation, humification, pollination, water retention and nutrient cycling;
Amendment 27 #
2015/2227(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas because of biologically limited energy transfer efficiencies between trophic levels, it is more resource-efficient for humans to produce and consume much more vegetable protein; indeed as part of leguminous crop rotations as practiced since the middle ages it provides for a more fertile and productive soil due to nitrogen fixation in nodules;
Amendment 31 #
2015/2227(INI)
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas cows and other ruminants have evolved to eat grass, or rather digest the bacteria that break down the grass, to obtain the protein they need; whereas as dairy farmers globally suffer due to overproduction of European milk, agronomists are increasingly questioning a soya dependency that means cows are fed like Olympic athletes in order to produce the most milk they can simply to oversupply an already-saturated market;
Amendment 37 #
2015/2227(INI)
Motion for a resolution
Recital D
Recital D
D. whereas despite the numerous challenges and the growing number of standards farmers have to deal with, EU consumers have never spent a smaller percentage of their income on food; whereas prices of goods from other sectors of the economy have increased over the decades, food prices have intentionally been kept low in the USA and the EU and this has had the effect of squeezing farmers as costs of production have increased faster than farm gate prices;
Amendment 43 #
2015/2227(INI)
Motion for a resolution
Recital E
Recital E
E. whereas consumers are demanding food production with higher environmental standards and nutritional value, while the agricultural sector needs to diversify and innovate to provide good quality and affordable food for all;
Amendment 53 #
2015/2227(INI)
Motion for a resolution
Recital F
Recital F
F. whereas owing to pressure on natural resources, climate change, the scarcity of land, the vulnerability of the environment, the growth of the world population and changing consumer behaviour, it is essential that farmers produce morebetter with less non-renewable resources, meaning a smaller ecological footprint per kg of product produced;
Amendment 63 #
2015/2227(INI)
Motion for a resolution
Recital G
Recital G
G. whereas, a more productive, an equitable income and resource-efficient agriculture is key to addressing the challenges of sustainability for all farms of whatever size and to making them better equipped to preserve natural resources;
Amendment 88 #
2015/2227(INI)
Motion for a resolution
Recital K a (new)
Recital K a (new)
Ka. whereas a living, healthy soil will guarantee optimal defence and nutrition from beneficial organisms like mycorrhizae or free living nitrogen-fixing bacteria ; whereas these and other beneficial soil organisms are killed off by both synthetic fertiliser and pesticide use, stopping free delivery of the full range of macro- and micro-nutrients and minerals to the plant, rather than only nitrogen and phosphorous in fertilisers which are mostly lost as pollutants in water ; whereas such complete nutrition from a living soil ensures plants grow robustly and resist pest attack better, and that plants are more nutritious and the animals eating them are also healthier ; whereas mycorrhizae act not only as a barrier against pathogenic organisms, but also symbiotically provide crops water and nutrients in exchange for sugars exuded by plant roots;
Amendment 93 #
2015/2227(INI)
Motion for a resolution
Recital K b (new)
Recital K b (new)
Kb. whereas a living, healthy soil will guarantee optimal defence and nutrition from beneficial organisms like mycorrhizae or free living nitrogen-fixing bacteria ; whereas these and other beneficial soil organisms are killed off by both synthetic fertiliser and pesticide use, stopping free delivery of the full range of macro- and micro-nutrients and minerals to the plant, rather than only nitrogen and phosphorous in fertilisers which are mostly lost as pollutants in water ; whereas such complete nutrition from a living soil ensures plants grow robustly and resist pest attack better, and that plants are more nutritious and the animals eating them are also healthier ; whereas mycorrhizae act not only as a barrier against pathogenic organisms, but also symbiotically provide crops water and nutrients in exchange for sugars exuded by plant roots;
Amendment 96 #
2015/2227(INI)
Motion for a resolution
Recital K c (new)
Recital K c (new)
Kc. whereas organic farming represents such a fusion of longstanding techniques with innovative ones, based on living, self- regenerating and self-strengthening systems;
Amendment 123 #
2015/2227(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Recalls that between 30-50% of the food produced in the EU is wasted, and although it is difficult to measure and it occurs at varying rates according to sector and occurs at different stages of the production and supply chain in different parts of the world there is some consensus that the global average of food waste is around 30%; Urges for a better management of food produces to avoid food waste;
Amendment 132 #
2015/2227(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Notes that in 2013, the USA-based multinational Monsanto purchased the Climate Corporation, which owns the data of the farmers using precision farming technology; Calls on the Commission warns not to take such an approach in the EU;
Amendment 175 #
2015/2227(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Emphasises the enormous potential of technology and innovation for the development of new products and services and job creation along the whole agri-food value chain; highlights the creation of new jobs in the agricultural sector, which is of pivotal importance for rural development, rural repopulation and economic growth, and considers that developing modern agricultural practices will make agriculture more attractive to young farmers and entrepreneurs alike; calls on the Commission to look into the possibilities of incentivising farmers to raise public awareness concerning the workings of the agri-food chain and new production methods;
Amendment 226 #
2015/2227(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Considers soil quality to be of a major and vital economic and ecological importance since a depletion of the ecological state would result in less productive soil, lower nutrient availability, increases in susceptibility of plants to pests and diseases, lower water holding capacity and diminished biodiversity; callUrges on the Commission to support innovative practices and the sharing of best practices such as crop rotation systems or fertilising with green legumes to avoid further soil degradation; believes that the interplay between organic matter and production needs to be better understood; welcomes research into innovative practices such as the use of microbial interventions and plant-soil interactions which could lower the environmental impact and reduce the use of chemical fertilisers and pesticides; recognises the importance of a sustainable soil use that takes account of site-specific needs;
Amendment 242 #
2015/2227(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Reminds that a pesticide is a substance intended to kill living things, mostly by interfering with respiratory and metabolic pathways common to many species, so that all problems with pesticides has always been an inability to target the pest species, resulting in collateral damage to other life forms in the agro-ecosystem including soil life; Notes that species beneficial to crop plants, defending their roots and providing water and nutrition in the soil and preying on pests above ground, are also killed, meaning that crops become susceptible to future attacks;
Amendment 258 #
2015/2227(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Notes with concern the trend towards breeding seed to be dependent upon agro- chemicals, and using a prophylactic approach by coating seeds with pesticides, as this prevents the natural nutrition and defence mechanisms found in living, healthy soils and biologically diverse agro-ecosystems to resist pest attack, preventing integrated approaches such as IPM from working properly, as well as locking farmers in to chemical dependency and increasing susceptibility to future attacks;
Amendment 260 #
2015/2227(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18b. Regrets that the approval process for non-chemical alternatives to plant protection products such as biological controls and nature-based solutions is the same as for conventional pesticides and biocides; notes the huge success of biological and nature-based controls especially in the fruit sector; calls therefore for easing of these restrictions, notwithstanding due attention to be given to avoid release of alien species;
Amendment 309 #
2015/2227(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Considers innovation to be an essential tool and a key horizontal policy priority for the CAP to develop, implement and achieve the objectives of the CAP reform 2014-2020; calls on the Commission, therefore, to provide a more ambitious overarching strategy with measurable outcomes in order to align and focus research and innovation vis-à-vis policy priorities; stresses that the CAP should provide more flexibility for the use of newly developed techniques and practices without an increase in burdensome rules and procedures; believes that a horizontal priority for the European legislative framework should be to ensure sufficient leeway for pilot programmes and testing for innovative techniques;
Amendment 7 #
2015/0218(COD)
Proposal for a regulation
–
–
The Committee on Agriculture and Rural Development calls on the Committee on International Trade, as the committee responsible, to propose that the Commission proposal should be rejected.
Amendment 8 #
2015/0218(COD)
Proposal for a regulation
Citation 1 a (new)
Citation 1 a (new)
Having regard to Decision No 534/2014/EU of the European Parliament and of the Council of 15 May 2014 providing EUR 300 million in macro- financial assistance to the Republic of Tunisia,
Amendment 5 #
2014/2228(INI)
Draft opinion
Recital A
Recital A
A. whereas the EU agricultural sector is a very sensitive and essential part of the TTIP negotiations and one in which the EU, which already enjoys a significant trade surplus with the US, stands to benefit greatly from new or increased market access opportunitierisks losing its prerogatives and specific features with regard to the protection of local products;
Amendment 40 #
2014/2228(INI)
Draft opinion
Recital C
Recital C
C. whereas respect for food safety and human and animal health standards willmust be a fundamental tenet of the negotiations for European agriculture;
Amendment 84 #
2014/2228(INI)
Draft opinion
Paragraph 1 – point a
Paragraph 1 – point a
a. prioritise an ambitious and balanced result of the negotiations for agriculture, the three main components of which (market access, geographical indications and, sanitary and phytosanitary measures) should and protection of animal welfare) must be tackled early and in parallel in the negotiation process, in order to give Parliament enough time to discuss and evaluate this chapter with stakeholders and Europepresenting a transparent offer concerning the agricultural products negotiated, thus giving Parliament enough time to discuss and evaluate what the priorities of EU farmers are in relation to the requirements of the EU internal market and citizensonsumer health;
Amendment 108 #
2014/2228(INI)
Draft opinion
Paragraph 1 – point b
Paragraph 1 – point b
b. firmly commit toguarantee the strict preservation of standards on food safety and human and animal health, as defined under EU legislation, and ensure that fundamental values of the EU such as the precautionary principle and the ban on animal testing are not undermined;
Amendment 138 #
2014/2228(INI)
Draft opinion
Paragraph 1 – point c
Paragraph 1 – point c
c. ensure a positive final outcome ofconclude the negotiations for agriculture reflecting boin in a way that is consistent with the offensive and defensive interests of the EU agricultural sector concerning the abolition or reduction of both tariff and non-tariff barriers, including in particular sanitary and phytosanitary standards and procedures, so that EU producers make genuine gains whilst respecting the level of standards already established in Europe and the protection of European geographical indications, preventing terms of acchem from becoming generic namess to the US marketdetriment of specific local features and employment in rural areas;
Amendment 144 #
2014/2228(INI)
Draft opinion
Paragraph 1 – point c a (new)
Paragraph 1 – point c a (new)
ca. ask the US to provide us with a traceability system for food products exported to Europe, especially with regard to meat and milk, and to prevent food from clones or their offspring from being imported; stresses, moreover, the need to comply with the EU rules already in force which prohibit the use of growth hormones and antibiotics in animals for slaughter and the use of animal feed from genetically modified organisms (GMOs);
Amendment 188 #
2014/2228(INI)
Draft opinion
Paragraph 1 – point e
Paragraph 1 – point e
e. secure significantly improved protection of EU geographical indications and better consumer information as an essential element of a balanced agreement, takpreventing typical European products from adopting a generic name, alongside appropriate, transparent information for consumers, replicating the relevant chapter of the CETA with Canada as a good example;
Amendment 213 #
2014/2228(INI)
Draft opinion
Paragraph 1 – point f
Paragraph 1 – point f
f. engage in a fully transparent, timely and comprehensive manner with all agricultural and animal husbandry stakeholders on all aspects of the negotiations.
Amendment 19 #
2014/2146(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas livestock farming is particularly vulnerable to the challenges of volatility, which affects both income and cost aspects;
Amendment 70 #
2014/2146(INI)
Motion for a resolution
Recital J
Recital J
J. whereas European dairy products and, in particular, PDO, PGI and TSG products, significantly contribute to the success of the EU’s agri-food industry and the prosperity of rural economies;
Amendment 111 #
2014/2146(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Urges the Commission to tackle the problem of price volatility by creating a platform for monitoring prices and quantities traded in order to anticipate anomalous market movements, and establish a suitable voluntary income guarantee mechanism, as provided for in the CAP reform;
Amendment 345 #
2014/2146(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Underlines that bilateral trade negotiations may represent strategic opportunities for the EU dairy sector, with particular regard to PDO, PGI and TSG products that fall within protected geographical indications which are widely flouted by non-EU countries, and urges the Commission to take due regard of this issue during trade negotiations which concern these products;
Amendment 399 #
2014/2146(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Notes that the sector has not engaged with the Protected Designation of Origin (PDO) and, Protected Geographical Indications (PGI) and Traditional Speciality Guaranteed (TSG) schemes in a meaningful manner; calls on the Commission to simplify access to these schemes in full respect of competition rules;
Amendment 39 #
2014/0257(COD)
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) This regulation aims at ensuring a high level of protection of both animal and human health while securing the protection of the environment. The precautionary principle should be applied and this Regulation should ensure that industry demonstrates that pharmaceutical substances or veterinary medicinal products produced or placed on the market have no harmful effects on human or animal health nor any unacceptable effects on the environment.
Amendment 97 #
2014/0257(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
2. In addition to the products referred to in paragraph 1, Chapter VI shall also apply to active substances, intermediate products and excipientactive substances used as starting materials in veterinary medicinal products.
Amendment 128 #
2014/0257(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point b
Article 7 – paragraph 2 – point b
(b) information about risk mitigation measures to limit antimicrobial resistance development related to the use of veterinary medicinal product, including that the product is not to be used as a routine prophylactic measure in food producing animals, unless specifically authorised by CVMP.
Amendment 135 #
2014/0257(COD)
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. The immediate packaging of a veterinary medicinal product shall contain only the following information: only be required to contain the information set out below. Additional information consistent with Article 30 may be included where space allows.
Amendment 141 #
2014/0257(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point f
Article 10 – paragraph 1 – point f
(f) requirement to use take-back schemes for veterinary medicinal products forspecific precautions relating to the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions as regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products reference to any appropriate collection system in place;
Amendment 154 #
2014/0257(COD)
Proposal for a regulation
Article 16 – paragraph 5
Article 16 – paragraph 5
5. The clinical information of the summary of the product characteristics (as defined in Article 30(1)(c), excluding point (vi)) of the generic veterinary medicinal product shall be identical to that of the reference veterinary medicinal product. However, thatis requirement shall not apply to: (a) those parts of the summary of the product characteristics of the reference veterinary medicinal product that refer to indications or pharmaceutical forms which are still covered by patent law or protection of technical documentation (Articles 33 to 36) at the time when the generic veterinary medicinal product is authorised or (b) a subsequent amendment of the reference medicinal product.
Amendment 160 #
2014/0257(COD)
Proposal for a regulation
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
By way of derogation from Article 7(1)(b) an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have eachwhere one or more have already been used in authorised veterinary medicinal products, but have not hitherto been authorised in that combination (‘combination veterinary medicinal product'’) shall satisfy the following criteria:
Amendment 161 #
2014/0257(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) the applicant can demonstrate that the veterinary medicinal product icontains a combination ofwith at least one reference veterinary medicinal products as referred to in Article 16(1)(b);
Amendment 162 #
2014/0257(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point d
Article 17 – paragraph 1 – point d
(d) where needed, appropriate documentation on the safety of that combination is provided.
Amendment 163 #
2014/0257(COD)
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
By way of derogation from Article 16(1)(b), an applicant for a marketing authorisation for a generic veterinary medicinal product shall not be required to provide the documentation on safety and efficacy if he demonstrates in the form of a letter of access that he is allowed to use the documentation on safety and efficacy referred to in Article 7(1)(b) which is available forfor which he has a relevant letter of access to the documentation of the reference veterinary medicinal product.
Amendment 175 #
2014/0257(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point c – point vi
Article 30 – paragraph 1 – point c – point vi
(vi) frequency and seriousness of adverse events or reactions,
Amendment 176 #
2014/0257(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point c – point viii
Article 30 – paragraph 1 – point c – point viii
(viii) known interaction with other medicinal products and other known forms of interaction,.
Amendment 179 #
2014/0257(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point c – point xiii
Article 30 – paragraph 1 – point c – point xiii
(xiii) special conditions for use, including restrictions on the use of antimicrobials in order to limit the risk of development of antimicrobial resistance, and specifying that the product is not to be used as a routine preventative measure in food producing animals,
Amendment 181 #
2014/0257(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point e – point viii
Article 30 – paragraph 1 – point e – point viii
(viii) requirement to use take-back schemes for veterinary medicinal products forspecific precautions relating to the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products reference to any appropriate collection system in place;
Amendment 205 #
2014/0257(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
2. In addition to the products referred to in paragraph 1, Chapter VI shall also apply to active substances, intermediate products and excipientactive substances used as starting materials in veterinary medicinal products.
Amendment 217 #
2014/0257(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point c
Article 34 – paragraph 1 – point c
(c) 1820 years for veterinary medicinal products for bees;
Amendment 219 #
2014/0257(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point d
Article 34 – paragraph 1 – point d
(d) 146 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c).
Amendment 230 #
2014/0257(COD)
Proposal for a regulation
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Where a variation is approved in accordance with Article 65 extending the marketing authorisation to a another species not listed in Article 34(1)(a), the period of the protection provided for in Article 34 shall be prolonged by 46 years.
Amendment 235 #
2014/0257(COD)
Proposal for a regulation
Article 35 – paragraph 3
Article 35 – paragraph 3
3. The period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation ( ' 'overall period of the protection of technical documentation ' ') shall not exceed 1820 years.
Amendment 301 #
2014/0257(COD)
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. The immediate packaging of a veterinary medicinal product shall contain only the following information:only be required to contain the information set out below. Additional information consistent with Article 30 may be included where space allows.
Amendment 311 #
2014/0257(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point f
Article 10 – paragraph 1 – point f
(f) requirement to use take-back schemes for veterinary medicinal products forspecific precautions relating to the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions as regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products reference to any appropriate collection systems already in place;
Amendment 313 #
2014/0257(COD)
Proposal for a regulation
Article 73 – paragraph 2 – point d
Article 73 – paragraph 2 – point d
Amendment 317 #
2014/0257(COD)
Proposal for a regulation
Article 74 – paragraph 1
Article 74 – paragraph 1
1. The Agency shall establish and maintain a Union database on pharmacovigilance of veterinary medicinal products (the ‘pharmacovigilance database')’), linked with the Product database. The Union database shall be the sole point of receipt for adverse events submitted by the MAHs.
Amendment 318 #
2014/0257(COD)
Proposal for a regulation
Article 74 – paragraph 2
Article 74 – paragraph 2
2. The Agency shall, in collabornsultation with the Member States and, the Commission, and interested parties, draw up the functional specifications for the pharmacovigilance database.
Amendment 320 #
2014/0257(COD)
Proposal for a regulation
Article 74 – paragraph 3
Article 74 – paragraph 3
3. The Agency shall ensure that information reported to the pharmacovigilance database is uploaded and made publicly accessible in accordance with Article 75.
Amendment 322 #
2014/0257(COD)
Proposal for a regulation
Article 76 – paragraph 2
Article 76 – paragraph 2
2. Marketing authorisation holders shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products, within 30 days following the receipt of the adverse event report. Different requirements shall apply for adverse events observed in clinical trials.
Amendment 324 #
2014/0257(COD)
Proposal for a regulation
Article 76 – paragraph 3
Article 76 – paragraph 3
3. CIn the event of a serious safety concern, competent authorities may, on their own initiative or on request from the Agency, request the marketing authorisation holder to collect specific pharmacovigilance data, in particular regarding the use of a veterinary medicinal product in specified animal species, in the context of public and animal health, safety of the persons administering the product, and the protection of the environment. The authority shall state in detail the reasons for the request and inform other competent authorities and the Agency thereof.
Amendment 331 #
2014/0257(COD)
Proposal for a regulation
Article 77 – paragraph 6
Article 77 – paragraph 6
6. The marketing authorisation holder shall not communicate information regarding adverse events and potential pharmacovigilance concerns to the general public in relation to the veterinary medicinal product without giving prior notification of his intention to the competent authority or authorities having granted the marketing authorisation or to the Agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure.
Amendment 332 #
2014/0257(COD)
Proposal for a regulation
Article 78 – paragraph 1 – point a
Article 78 – paragraph 1 – point a
(a) elaborating and maintaining a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to the veterinary medicinal product for which the authorisation has been granted (‘pharmacovigilance system master file’) for all products under their responsibility;
Amendment 333 #
2014/0257(COD)
Proposal for a regulation
Article 78 – paragraph 1 – point b
Article 78 – paragraph 1 – point b
(b) allocating reference numbers to the pharmacovigilance system master file and communicating the relevant reference number of the pharmacovigilance master file of each product to the product database for each product;
Amendment 340 #
2014/0257(COD)
Proposal for a regulation
Article 16 – paragraph 5
Article 16 – paragraph 5
5. The clinical information in the summary of the product characteristics (as defined in Article 30(1)(c), excluding point (vi)) of the generic veterinary medicinal product shall be identical to that of the reference veterinary medicinal product. However, that requirement shall not apply to those parts of the summary of the product characteristics of the reference veterinary medicinal product that refer to indications or pharmaceutical forms which are still covered by patent law at the time when the generic veterinary medicinal product is authorised.:
Amendment 341 #
2014/0257(COD)
Proposal for a regulation
Article 16 – paragraph 5 – point a (new)
Article 16 – paragraph 5 – point a (new)
(a) those parts of the summary of the product characteristics of the reference veterinary medicinal product that refer to indications or pharmaceutical forms which are still covered by patent law or arrangements for the protection of technical documentation (Articles 33 to 36) at the time when authorisation is granted for the generic veterinary medicinal product or
Amendment 342 #
2014/0257(COD)
Proposal for a regulation
Article 16 – paragraph 5 – point b (new)
Article 16 – paragraph 5 – point b (new)
(b) any subsequent changes to the reference medicinal product.
Amendment 348 #
2014/0257(COD)
Proposal for a regulation
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
By way of derogation from Article 7(1)(b) an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have eachone or more of which have already been used in authorised veterinary medicinal products, but have not hitherto been authorised in that combination (‘combination veterinary medicinal product’) shall satisfy the following criteria:
Amendment 349 #
2014/0257(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) the applicant can demonstrate that the veterinary medicinal product icontains a combination ofwith at least one reference veterinary medicinal products as referred to in Article 16(1)(b);
Amendment 350 #
2014/0257(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point d
Article 17 – paragraph 1 – point d
(d) where necessary, appropriate documentation on the safety of that combination is provided.
Amendment 351 #
2014/0257(COD)
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
By way of derogation from Article 16(1)(b), an applicant for a marketing authorisation for a generic veterinary medicinal product shall not be required to provide the documentation oin safety and efficacy if he demonstrates in the form of a letter of access that he is allowed to use the documentation on safety and efficacy referred to in Article 7(1)(b) which is availablerespect of which he has a relevant letter of access to the documentation for the reference veterinary medicinal product.
Amendment 397 #
2014/0257(COD)
Proposal for a regulation
Article 115 – paragraph 1 – introductory part
Article 115 – paragraph 1 – introductory part
1. By way of derogation from Article 111, where there is no authorised veterinary medicinal product in a Member State for a condition affecting a non-food producing animal, the veterinarian responsible may, under his/her direct personal responsibility and in particular to avoid causing unacceptable suffering, exceptionally treat the animal concerned with the following, with the exception of anticrobial products used as routine prophylactic measure, unless specifically authorised by the CVMP:
Amendment 401 #
2014/0257(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point c – point viii
Article 30 – paragraph 1 – point c – point viii
(viii) known interaction with other medicinal products and other known forms of interaction,
Amendment 407 #
2014/0257(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point e – point viii
Article 30 – paragraph 1 – point e – point viii
(viii) requirement to use take-back schemes for veterinary medicinal products forspecific precautions relating to the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products reference to any appropriate collection system in place;
Amendment 420 #
2014/0257(COD)
Proposal for a regulation
Article 116 – paragraph 4 – subparagraph 1
Article 116 – paragraph 4 – subparagraph 1
The Commission may, by means of implementing acts, establish a list of veterinary medicinal products authorised in the Union for use in terrestrial animals which can be used for treatment of food- producing animals of an aquatic species in accordance with paragraph 1. This provision is strictly limited to closed aquatic systems with specific waste water treatment facilities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Amendment 437 #
2014/0257(COD)
Proposal for a regulation
Article 125 – paragraph 1
Article 125 – paragraph 1
1. Competent authorities shall performensure common controls of manufacturers, importers, marketing authorisation holders, wholesale distributors and suppliers of the veterinary medicinal products regularly, on a risk- basis, in order to verify that the requirements as set out in this Regulation are complied with.
Amendment 442 #
2014/0257(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point c
Article 34 – paragraph 1 – point c
(c) 1820 years for veterinary medicinal products for bees;
Amendment 442 #
2014/0257(COD)
Proposal for a regulation
Article 125 – paragraph 4 – subparagraph 2
Article 125 – paragraph 4 – subparagraph 2
Amendment 443 #
2014/0257(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point d
Article 34 – paragraph 1 – point d
(d) 146 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c).
Amendment 444 #
2014/0257(COD)
Proposal for a regulation
Article 125 – paragraph 6
Article 125 – paragraph 6
6. IFinal inspection reports shall be uploaded to the appropriate database, with continuous access for all competent authorities, and shall be made public.
Amendment 451 #
2014/0257(COD)
Proposal for a regulation
Article 35 – paragraph 2
Article 35 – paragraph 2
2. Where a variation is approved in accordance with Article 65 extending the marketing authorisation to a another species not listed in Article 34(1)(a), the period of the protection provided for in Article 34 shall be prolonged by 46 years.
Amendment 456 #
2014/0257(COD)
Proposal for a regulation
Article 35 – paragraph 3
Article 35 – paragraph 3
3. The period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation ( ' 'overall period of the protection of technical documentation ' ') shall not exceed 1820 years.
Amendment 582 #
2014/0257(COD)
Proposal for a regulation
Article 73 – paragraph 2 – point d
Article 73 – paragraph 2 – point d
Amendment 596 #
2014/0257(COD)
Proposal for a regulation
Article 74 – paragraph 1
Article 74 – paragraph 1
1. The Agency shall establish and maintain a Union database on pharmacovigilance of veterinary medicinal products (the " ‘pharmacovigilance database " )’), linked with the product database. The Union database shall be the sole point of receipt for adverse events submitted by the marketing authorisation holders.
Amendment 597 #
2014/0257(COD)
Proposal for a regulation
Article 74 – paragraph 2
Article 74 – paragraph 2
2. The Agency shall, in collabornsultation with the Member States and, the Commission and interested parties, draw up the functional specifications for the pharmacovigilance database.
Amendment 610 #
2014/0257(COD)
Proposal for a regulation
Article 76 – paragraph 2
Article 76 – paragraph 2
2. Marketing authorisation holders shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the Union or in a third country with regard to their authorised veterinary medicinal products, within 30 days following the receipt of the adverse event report. Different requirements shall apply for adverse events observed in clinical trials.
Amendment 613 #
2014/0257(COD)
Proposal for a regulation
Article 76 – paragraph 3
Article 76 – paragraph 3
3. CIn the event of serious safety concerns, competent authorities may, on their own initiative or on request from the Agency, request the marketing authorisation holder to collect specific pharmacovigilance data, in particular regarding the use of a veterinary medicinal product in specified animal species, in the context of public and animal health, safety of the persons administering the product, and the protection of the environment. The authority shall state in detail the reasons for the request and inform other competent authorities and the Agency thereof.
Amendment 630 #
2014/0257(COD)
Proposal for a regulation
Article 78 – paragraph 1 – point a
Article 78 – paragraph 1 – point a
(a) elaborating and maintaining a detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to the veterinary medicinal product for which the authorisation has been granted (‘pharmacovigilance system master file’) for all products under their responsibility;
Amendment 632 #
2014/0257(COD)
Proposal for a regulation
Article 78 – paragraph 1 – point b
Article 78 – paragraph 1 – point b
(b) allocating reference numbers to the pharmacovigilance system master file and communicating the relevant reference number of the pharmacovigilance master file of each product to the product database for each product;
Amendment 37 #
2013/0443(COD)
Proposal for a directive
Recital 8 a (new)
Recital 8 a (new)
(8a) Regardless of the not inconsiderable contribution made by the agricultural sector to increasing emissions of atmospheric pollutants, it must be remembered that the commitment to reduce greenhouse gas emissions by 17 % made in recent years was a far higher figure than that established by the Kyoto Protocol in regard of national objectives.
Amendment 55 #
2013/0443(COD)
Proposal for a directive
Recital 13
Recital 13
(13) In order to reduce atmospheric NH3 and PM2,5 emissions from the main contributors, national air pollution control programmes should include measures applicable to the agricultural sectorand livestock sector which, together with enteric fermentation emissions and manure management measures, contribute to approximately half of greenhouse gas emissions. Member States should be entitled to implement measures other than those set out in this Directive with an equivalent level of environmental performance owning to specific and documented national circumstances.
Amendment 165 #
2013/0443(COD)
Proposal for a directive
Article 15
Article 15
Member States shall lay down the rules on themeasures and penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive, dissuasive and shall ensure a level playing field. Member States shall notify those provisions to the Commission by [date for transposition of the Directive] at the latest and shall notify it without delay of any subsequent amendment affecting them.
Amendment 214 #
2013/0443(COD)
Proposal for a directive
Annex III – part 1 – section A – point 3 – point b
Annex III – part 1 – section A – point 3 – point b
(b) urea-based fertilizers shall as far as possible be replaced by ammonium nitrate-based fertilizersbe prohibited;
Amendment 219 #
2013/0443(COD)
Proposal for a directive
Annex III – part 1 – section A – point 3 – point d
Annex III – part 1 – section A – point 3 – point d
(d) inorganic fertilisers shall be replaced by organic fertilisers. Where inorganic fertilisers are applied, these shall be spread in line with the foreseeable requirements of the receiving crop or grassland with respect to nitrogen and phosphorus, also taking into account the existing nutrient content in the soil and the nutrients from other fertilizers.
Amendment 223 #
2013/0443(COD)
Proposal for a directive
Annex III – part 1 – section A – point 4 – point a – point iv a (new)
Annex III – part 1 – section A – point 4 – point a – point iv a (new)
(iva) waste, slurries and manures shall be spread during winter in order to minimise nitrate leaching and percolation and avoid subjecting same to the high temperatures prevailing in spring and summer.
Amendment 224 #
2013/0443(COD)
Proposal for a directive
Annex III – part 1 – section B – point 2 – point d a (new)
Annex III – part 1 – section B – point 2 – point d a (new)
(da) agronomic soil management;
Amendment 225 #
2013/0443(COD)
Proposal for a directive
Annex III – part 1 – section B – point 2 – point d b (new)
Annex III – part 1 – section B – point 2 – point d b (new)
(d b) optimised fertilisation methods and introduction of techniques such as anaerobic digestion of effluents with biogas production.
Amendment 32 #
2013/0435(COD)
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 benefitting their social and economic interests. Differences between national laws concerning the safety assessment and authorisation of novel foods may hinder the free movement of such food, thereby creating unfair conditions of competition, as well as among agri-food business operators and SMEs.
Amendment 58 #
2013/0435(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) The placing on the market within the Union of traditional foods from third countries should be facilitated, where the history of safe food use in a third country has been demonstrated. Those foods should have been consumed in a third country for at least 25 years as a part of the customarnormal daily diet within a large part of the population of the country. Their safety assessment and management must take into account their history of safe food use should not inin the third country, excludeing non- - food uses or, uses not related to normal diets and uses for medical purposes.
Amendment 86 #
2013/0435(COD)
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21a) The safety assessment and post market monitoring shall consider whether the compositional parameters of novel foods are subjected to significant changing due to lower hygienic controls and poor agriculture practices.
Amendment 91 #
2013/0435(COD)
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 bet is 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, especially for those coming from third countries.
Amendment 96 #
2013/0435(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) The Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and should take all measures necessary to ensure that they are implemented. Those penalties should beall be harmonised, effective, proportionate and dissuasive.
Amendment 108 #
2013/0435(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) genetically modified foods and their derivatives falling within the scope of Regulation (EC) No 1829/2003;
Amendment 138 #
2013/0435(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point a – point iv a (new)
Article 2 – paragraph 2 – point a – point iv a (new)
(iva) food ingredients as botanical sources used or intended to be used for medical purposes falling with the scope of Directive 2001/83/EC;
Amendment 139 #
2013/0435(COD)
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 processed derivatives as defined in Regulation (EC) No 178/2002, with a history of safe food use and significant consumption in a third country;
Amendment 140 #
2013/0435(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point c
Article 2 – paragraph 2 – point c
(c) ‘history of safe food use in a third country’ means that the safety of the food in question has been confirmed with compositional data and from experience of continued use and significant consumption for at least 25 years in the customarnormal daily diet of a large part of the population or geographical region of a third country, prior to a notification referred to in Article 13;
Amendment 142 #
2013/0435(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point e a (new)
Article 2 – paragraph 2 – point e a (new)
(ea) "compositional data" means detailed sets of information on the nutritionally important components of food and its chemical compositions which have to remain stable under different climatic and environment conditions in order to confirm the safety of foods, especially those coming from third countries.
Amendment 150 #
2013/0435(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Food business operators shall verify whether or not the status of the food which they intend to place on the market within the Union falls within the scope of this Regulation.
Amendment 157 #
2013/0435(COD)
Proposal for a regulation
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
2a. Where necessary, agri-food business operators may consult other competent authorities and the Commission which shall communicate the result of the consultation to all Member States.
Amendment 165 #
2013/0435(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The Commission shall establish and update a Union list of novel foods authorised, which shall include a list of traditional food from third countries, to be placed on the market within the Union in accordance with Articles 6, 7 and 8 (‘"the Union list’").
Amendment 166 #
2013/0435(COD)
Proposal for a regulation
Article 5 – paragraph 1 a (new)
Article 5 – paragraph 1 a (new)
1a. The Union list shall be made public.
Amendment 167 #
2013/0435(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Only novel foods authorised and included in the Union list or in the list of traditional foods from third countries may be placed on the market within the Union as such and used in or on foods under the conditions of use specified therein.
Amendment 172 #
2013/0435(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a
Article 6 – paragraph 1 – point a
(a) it does not, on the basis of the scientific evidence available, pose a safety risk to human health, under normal consumption conditions and under different climatic and environmental ones;
Amendment 176 #
2013/0435(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point b
Article 6 – paragraph 1 – point b
(b) its use does not mislead the consumer, even to a material degree;
Amendment 191 #
2013/0435(COD)
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 199 #
2013/0435(COD)
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, the intended use of the food and its origin, which renders a novel food no longer equivalent to an existing food or of implications for the health of specific groups of the population;
Amendment 255 #
2013/0435(COD)
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.
Amendment 291 #
2013/0435(COD)
Proposal for a regulation
Article 26
Article 26
Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be harmonised, effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by …26 at the latest and shall notify it without delay of any subsequent amendment affecting them. __________________ 26 Publications Office: please insert date: 24 months after the date of entry into force of this Regulation.
Amendment 302 #
2013/0435(COD)
Proposal for a regulation
Article 27 a (new)
Article 27 a (new)
Article 27a Review No later than 3 years after the date of application of this Regulation and in the light of experience gained, the Commission shall forward to Parliament and Council a report on its implementation and, in particular, of Articles 3 and 8, accompanied, where appropriate, by any proposals. The report shall be made public.