Activities of Maria Lidia SENRA RODRÍGUEZ related to 2016/0084(COD)
Plenary speeches (1)
CE marked fertilising products (debate) PT
Amendments (28)
Amendment 57 #
Proposal for a regulation
Recital 2
Recital 2
(2) Certain products are being used in combination with fertilisers for the purpose of improving nutrition efficiency, with the beneficial effect of reducing the amount of fertilisers used and hence their environmental impact. In order to facilitate their free movement on the internal market, not only fertilisers, i.e. products intended to provide plants with nutrient, but also products intended to improve plants’ nutrition efficiency, should be covered by the harmonisation, excluding hormones and genetically manipulated products.
Amendment 65 #
Proposal for a regulation
Recital 8
Recital 8
(8) Contaminants in CE marked fertilising products, such as cadmium, can potentially pose a risk to human and animal health and the environment as they accumulate in the environment and enter the food chain. Their content should therefore be limited in such products. Furthermore, impurities in CE marked fertilising products derived from bio-waste, in particular polymers but also metal and glass, should be either prevented or limited to the extent technically feasible by detection of such impurities in separately collected bio-waste before processing, such as cadmium, drug residues, pesticide residues and industrial waste.
Amendment 92 #
Proposal for a regulation
Recital 20
Recital 20
(20) A blend of different CE marked fertilising products, each of which has been subject to a successful assessment of conformity with the applicable requirements for that material, can itself be expected to be suitable for use as a CE marked fertilising product, subject only to certain additional requirements warranted by the blending. Therefore, in order to avoid an unnecessary administrative burden, such blends should belong to a separate category, for which the conformity assessment should be limited to the additional requirements warranted by the blending only if it is ruled to be in conformity with the blending requirements.
Amendment 93 #
Proposal for a regulation
Recital 23
Recital 23
(23) The manufacturer, having detailed knowledge of the design and production process, is best placed to carry outshall provide all such information to the confauthormity assessment procedure. Conformity assessment of CE marked fertilising products should therefore remain solely the obligation of the manufacturerresponsible for conformity assessment.
Amendment 95 #
Proposal for a regulation
Recital 24
Recital 24
Amendment 96 #
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24a) It will not be possible to introduce fertilizers with CE marking from third countries. This marking will be reserved exclusively for European Union products.
Amendment 97 #
Proposal for a regulation
Recital 25
Recital 25
Amendment 98 #
Proposal for a regulation
Recital 26
Recital 26
Amendment 99 #
Proposal for a regulation
Recital 27
Recital 27
Amendment 100 #
Proposal for a regulation
Recital 28
Recital 28
Amendment 102 #
Proposal for a regulation
Recital 39
Recital 39
(39) In order to ensure a consistent level of quality in the performance of conformity assessment of CE marked fertilising products, it is also necessary to set requirements for notifying authorities and other bodies involved inresponsible for the assessment, notification and monitoring of notified bodies.
Amendment 103 #
Proposal for a regulation
Recital 41
Recital 41
(41) Due to the variable nature of certain fertilising product component materials, and the potentially irreversible nature of some of the damages to which soil and crop exposure to impurities could lead, transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity of CE marked fertilising products containing such components, should be the only means of demonstrating the technical competence of conformity assessment bodies is the fact that they are public.
Amendment 104 #
Proposal for a regulation
Recital 42
Recital 42
(42) Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for CE marked fertilising products to be placed on the market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified and the monitoring of bodies already notified cover also activities carried out by subcontractors and subsidiariesbodies are public.
Amendment 107 #
Proposal for a regulation
Recital 47
Recital 47
(47) CE-marked fertilising products should be placed on the market only if they are sufficiently effective and do not present unacceptable risks to human, animal or plant health, to safety or to the environment when properly stored and used for their intended purpose, and under conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour. Therefore, requirements for safety and quality, as well as appropriate control mechanisms, should be established. Furthermore, the intended use of CE marked fertilising products should not lead to food or feed becoming unsafe.
Amendment 108 #
Proposal for a regulation
Recital 49
Recital 49
(49) The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to CE marked fertilising products presenting an unacceptable risk to human, animal or plant health, to safety or to the environment. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an early stage in respect of such fertilising products.
Amendment 110 #
Proposal for a regulation
Recital 53
Recital 53
(53) The examination procedure should be used for the adoption of implementing acts with respect to compliant CE marked fertilising products which present an unacceptable risk to human, animal or plant health, to safety or to the environment, since such acts fall within the ambit of Article 2(2) of Regulation (EU) No 182/2011. For the same reason, it should also be used for the adoption, amendment or repeal of common specifications.
Amendment 146 #
Proposal for a regulation
Article 6 – paragraph 8 – subparagraph 2
Article 6 – paragraph 8 – subparagraph 2
Furthermore, where manufacturers consider or have reason to believe that CE marked fertilising products which they have placed on the market present an unacceptable risk to human, animal or plant health, to safety or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the fertilising products available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.
Amendment 152 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. Before placing a CE marked fertilising product on the market importers shall ensure that the appropriate conformity assessment procedure referred to in Article 14 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the CE marked fertilising product is accompanied by the EU declaration of conformity and the required documents, and that the manufacturer has complied with the requirements set out in Article 6(5) and (6). Where an importer considers or has reason to believe that a CE marked fertilising product is not in conformity with the applicable requirements set out in Annex I, Annex II or Annex III, he or she shall not place the fertilising product on the market until it has been brought into conformity. Furthermore, where the CE marked fertilising product presents an unacceptable risk to human, animal or plant health, to safety or to the environment, the importer shall inform the manufacturer and the market surveillance authorities to that effect.
Amendment 153 #
Proposal for a regulation
Article 8 – paragraph 7 – subparagraph 2
Article 8 – paragraph 7 – subparagraph 2
Furthermore, where importers consider or have reason to believe that CE marked fertilising products which they have placed on the market present an unacceptable risk to human, animal or plant health, to safety or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the fertilising product available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.
Amendment 155 #
Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 2
Article 9 – paragraph 2 – subparagraph 2
Where a distributor considers or has reason to believe that a CE marked fertilising product is not in conformity with the applicable requirements set out in Annex I, Annex II or Annex III, he or she shall not make the fertilising product available on the market until it has been brought into conformity. Furthermore, where the CE marked fertilising product presents an unacceptable risk to human, animal or plant health, to safety or to the environment, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.
Amendment 156 #
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 2
Article 9 – paragraph 4 – subparagraph 2
Furthermore, where distributors consider or have reason to believe that CE marked fertilising products which they have made available on the market presents an unacceptable risk to human, animal or plant health, to safety or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the CE marked fertilising product available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.
Amendment 158 #
Proposal for a regulation
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
1a. The precautionary principle shall always prevail in the conformity assessment procedure.
Amendment 159 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The EU declaration of conformity shall have the model structure set out in Annex V, shall contain the elements specified in the relevant modules set out in Annex IV and shall be continuously updated. It shall be translated into the language or languages required byall the official languages in the Member State in which the CE marked fertilising product is placed or made available on the market.
Amendment 164 #
Proposal for a regulation
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
The production of fertilizers with sewage sludge shall not be authorised.
Amendment 165 #
Proposal for a regulation
Article 37 – paragraph 1 – subparagraph 1
Article 37 – paragraph 1 – subparagraph 1
Where the market surveillance authorities of one Member State have sufficient reason to believe that a CE marked fertilising product presents an unacceptable risk to human, animal or plant health, to safety or to the environment, they shall carry out an evaluation in relation to the fertilising product concerned covering the requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose.
Amendment 166 #
Proposal for a regulation
Article 39 – paragraph 1
Article 39 – paragraph 1
1. Where, having carried out an evaluation under Article 37(1), a Member State finds that although a CE marked fertilising product is in compliance with this Regulation it presents an unacceptable risk to human, animal or plant health, to safety or to the environment, it shall require the relevant economic operator to take all appropriate measures within a reasonable period to ensure that the fertilising product concerned, when placed on the market, no longer presents that risk, to withdraw the fertilising product from the market or to recall it.
Amendment 173 #
Proposal for a regulation
Article 42 – paragraph 1 – point b
Article 42 – paragraph 1 – point b
b) for which there is scientific evidence that the they do not present an unacceptable risk to human, animal or plant health, to safety or to the environment, and that they are sufficiently effective.
Amendment 182 #
Proposal for a regulation
Article 42 – paragraph 4
Article 42 – paragraph 4
4. The Commission shall also be empowered to adopt delegated acts in accordance with Article 43 to amend Annexes I to IV in the light of new scientific evidence. The Commission shall use this empowerment where, based on a risk assessment, an amendment proves necessary to ensure that any CE marked fertilising product complying with the requirements of this Regulation does not, under normal conditions of use, present an unacceptable risk to human, animal, or plant health, to safety or to the environment.