Activities of Mireille D'ORNANO related to 2018/0088(COD)
Plenary speeches (1)
Transparency and sustainability of the EU risk assessment in the food chain (debate) FR
Amendments (23)
Amendment 71 #
Proposal for a regulation
Recital 3
Recital 3
(3) The evaluation of Regulation (EC) No 178/200221, (“Fitness Check of the General Food Law”), found that risk communication is overall, not considered to be effective enough, which has an impact on consumers’ confidence on the outcome of the risk analysis process. Consumer confidence is being more generally undermined through the obvious lack of objectivity displayed by the Authority in assessing risks to human health from the use of glyphosate, declaring it to be harmless, although the International Agency for Research on Cancer ruled that it was ‘probably carcinogenic’. __________________ 21 Commission Staff Working Document, “The REFIT evaluation of the General Food Law (Regulation (EC) No 178/2002)”, SWD(2018)38 final, dated 15.1.2018.
Amendment 74 #
Proposal for a regulation
Recital 4
Recital 4
(4) It is therefore necessary to ensure a comprehensive and continuous risk communication process throughout risk analysis, involving Union and national risk assessors and risk managers. That process should be combined with an open dialogue between all interested parties to ensure the coherence and consistency within the risk analysis process. Generally speaking, it is the entire question of the independence of the Authority’s assessments that warrants close scrutiny.
Amendment 82 #
Proposal for a regulation
Recital 7
Recital 7
(7) Based on these general objectives and principles, a general plan on risk communication should be established in close cooperation with the Authority and, the Member States and their health authorities, which are frequently more independent than the Authority, and following relevant public consultations.
Amendment 85 #
Proposal for a regulation
Recital 8
Recital 8
(8) The general plan should identify the key factors to be taken into account and the best way of prioritising them when risk communications’ activities are considered, such as the different levels of risk, the nature of the risk and its potential public health impact, who and what are directly or indirectly affected by the risk, the levels of risk exposure, the ability to control risk and other factors that influence risk perception including the level of urgency as well as the applicable legislative framework and relevant market context. The general plan should also identify the tools and channels to be used and should establish appropriate mechanisms to ensure coherent risk communication.
Amendment 88 #
Proposal for a regulation
Recital 9
Recital 9
(9) Transparency of the risk assessment process contributes to the Authority acquiring greater legitimacy in the eyes of the consumers and general public in pursuing its mission, increases their confidence in its work and ensures that the Authority is more accountable to the Union citizens in a democratic system. It is therefore essential to maintain the confidence of the general public and other interested parties in the risk analysis process underpinning Union food law and in particular in the risk assessment, including the organisation and independence of the Authority and transparency. The confidence of the general public will be hard to win in view of the recent scandals that have undermined the reputation of the Authority, particularly as regards its independence.
Amendment 91 #
Proposal for a regulation
Recital 34 a (new)
Recital 34 a (new)
(34 a) whereas the second paragraph of point (a) of Article 2(4) of the Directive 2001/110/EC on honey provides that, where honey originates from more than one Member State or third country, the mandatory indication of the countries of origin may be replaced by one of the following, as appropriate: ‘blend of EU honeys’, ‘blend of non-EU honeys’ or ‘blend of EU and non-EU honeys’; whereas the indication ‘blend of EU and non-EU honeys’ is not informative enough for the consumer;
Amendment 92 #
Proposal for a regulation
Recital 34 b (new)
Recital 34 b (new)
(34 b) whereas many honey packagers and traders now abuse this way of indicating origin in order to conceal the real country of origin, as well as the proportion of honey from the different countries concerned, as purchasers are becoming more knowledgeable and are distrustful of foodstuffs from certain countries;
Amendment 93 #
Proposal for a regulation
Recital 34 c (new)
Recital 34 c (new)
(34 c) whereas the resolution of the European Parliament at 1 March 2018 on prospects and challenges for the EU apiculture sector “considers … that labelling such as ‘blend of EU honeys’, ‘blend of non-EU honeys’, and especially ‘blend of EU and non-EU honeys’, completely conceals the origin of the honey from the consumer and consequently fails to fulfil the principles of EU consumer protection law (paragraph 58)” and, therefore, “Asks for the ‘blend of EU and non-EU honeys’ descriptor on labels to be replaced by an indication of exactly which country or countries the honey used in the final product come from, and that these be listed in the order which corresponds to the percentage proportions used in the final product … (paragraph 59)
Amendment 94 #
Proposal for a regulation
Recital 11
Recital 11
(11) Experience shows that the role of the Management Board of the Authority is focussed on administrative and financial aspects and does not impact on the independence of the scientific work performed by the Authority. It is thus appropriate to include representatives of all Member States in the Management Board of the Authority, while providing that those representatives should have experience in particular on risk assessment.
Amendment 94 #
Proposal for a regulation
Recital 34 d (new)
Recital 34 d (new)
(34 d) whereas the situation on the EU internal honey market has been worsened due to the continuous import of adultered honey according to representatives of European and national beekeeper organisations; whereas the EU is not supposed to tolerate this situation anymore and it should take the right step forward which is the correction of the labelling section of the Directive 2001/110/EC on honey;
Amendment 95 #
Proposal for a regulation
Recital 34 e (new)
Recital 34 e (new)
(34 e) whereas current rules do not take account of fraudulent practices affecting processed products such as biscuits, breakfast cereals, confectionery, etc.; whereas the label ‘honey’ can mislead consumers in regard to the real content of the given product, as it is often used when much less than 50 % of the sugar content of the product originates from honey; whereas the food labelling rules has to be corrected also in this field;
Amendment 97 #
Proposal for a regulation
Recital 13
Recital 13
(13) The Fitness Check of the General Food Law identified certain shortcomings in the long-term capability of the Authority to maintain its high-level expertise. In particular, there has been a decrease in the number of candidates applying to be members of the Scientific Panels. The system has thus to be strengthened and Member States should take a more active role to ensure that a sufficient pool of experts is available to meet the needs of the Union risk assessment system in terms of high level of scientific expertise, independence and multidisciplinary expertise, without detracting from the quality of expertise within the national health authorities.
Amendment 105 #
Proposal for a regulation
Recital 14
Recital 14
(14) To preserve the independence of the risk assessment from risk management and from other interests at Union level, it is appropriate that the nomination of the members of the Scientific Panels by the Member States, their selection by the Executive Director of the Authority and their appointment by the Management Board of the Authority are based on strict criteria ensuring the excellence and independence of the experts while ensuring the required multidisciplinary expertise for each Panel. It is also essential to this end that the Executive Director whose function is to defend EFSA’s interests and in particular the independence of its expertise has a role in the selection and appointment of those scientific experts. Further measures should also be put in place to ensure that scientific experts have the means to act independently and that conflicts of interest are avoided a far as possible.
Amendment 110 #
Proposal for a regulation
Recital 16
Recital 16
(16) Authorisations procedures are based on the principle that it is for the applicant to prove that the subject matter of an authorisation procedure complies with Union safety requirements given the scientific knowledge in its possession. This principle is based on the premise that public health is better protected when the burden of proof is on the applicant since it has to prove that a particular subject matter is safe prior to its placing on the market, instead of the public authorities having to prove that a subject matter is unsafe in order to be able to ban it from the market. Moreover, public money should not be used to commission costly studies that will in the end help the industry to place a product on the market. According to this principle and in accordance with applicable regulatory requirements, in support of applications for an authorisation under Union sectoral food law applicants are required to submit relevant studies, including tests, to demonstrate the safety and in some cases the efficacy of a subject matter. Nevertheless, the Authority must itself be able to carry out the studies necessary to prove that an item is unsafe where doubts as to its safety or efficacy arise after it has been placed on the market.
Amendment 116 #
Proposal for a regulation
Recital 18
Recital 18
(18) The Authority should have knowledge of the subject matter of all studies performed by an applicant with a view to a future application for an authorisation under Union food law. To this end, it is necessary and appropriate that business operators commissioning the studies and laboratories carrying them out notify those studies to the Authority when commissioned in order to ensure that no studies commissioned by the applicant are concealed from the Authority, particularly if they produce results casting doubt on the safety or efficacy of the item under scrutiny. Information about the notified studies should be made public only once a corresponding application for authorisation has been made public in accordance with the applicable rules on transparency.
Amendment 126 #
Proposal for a regulation
Recital 20
Recital 20
(20) There are certain public concerns about the Authority’s assessment in the area of authorisation being primarily based on industry studies. These are legitimate concerns in view of the proven failure of the Authority to act independently in every case. The Authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment. In order to provide an additional level of guarantee ensuring that the Authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure, it is appropriate to provide for a consultation of third parties in order to identify whether other relevant scientific data or studies are available. To increase the effectiveness of the consultation, the consultation should take place when the studies submitted by industry included in an application for authorisation are made public, under the transparency rules of this Regulation.
Amendment 128 #
Proposal for a regulation
Recital 20
Recital 20
(20) There are csertainious public concerns about the Authority’s assessment in the area of authorisation being primarily based on industry studies. The Authority already makes searches in scientific literature to be able to consider other data and studies existing on the subject matter submitted to its assessment. In order to provide an additional level of guarantee ensuring that the Authority can have access to all relevant scientific data and studies available on a subject matter of an authorisation procedure, it is appropriate to provide for a consultation of third parties in order to identify whether other relevant scientific data or studies are available. To increase the effectiveness of the consultation, the consultation should take place when the studies submitted by industry included in an application for authorisation are made public, under the transparency rules of this Regulation.
Amendment 133 #
Proposal for a regulation
Recital 22
Recital 22
(22) Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment. Considering that it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the Commission should be responsible for triggering the commissioning of such verification studies. Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake (for example new scientific developments becoming available). This initiative, when considered together with the numerous efforts being made by certain Members of Parliament anxious to highlight the lack of independence of the Authority, necessitates a thorough review of the Authority’s risk assessment procedures.
Amendment 136 #
Proposal for a regulation
Recital 22
Recital 22
(22) Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment. Considering thatAlthough it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the Commission should not necessarily be responsible for triggering the commissioning of such verification studies. Such studies could also be commissioned by a Member State. Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake (for example new scientific developments becoming available).
Amendment 138 #
Proposal for a regulation
Recital 22
Recital 22
(22) Food safety is legitimately a sensitive matter of prime interest for all Union citizens. While maintaining the principle that the burden is on the industry to prove compliance with Union requirements, it is important to establish an additional verification tool to address specific cases of high societal importance where there is a controversy on safety issues, namely the commissioning of additional studies with the objective of verifying evidence used in the context of risk assessment. Considering that it would be financed by the Union budget and that the use of this exceptional verification tool should remain proportionate, the Commission should be responsible for triggering the commissioning of such verification studies. Account should be taken of the fact that in some specific cases the studies commissioned may need to have a wider scope than the evidence at stake (for example new scientific developments becoming available).
Amendment 149 #
Proposal for a regulation
Recital 27
Recital 27
(27) To determine what level of disclosure strikes the appropriate balance, the relevant rights of the public to transparency in the risk assessment process, should be weighted up against the rights of commercial applicants, taking into account the objectives of Regulation (EC) No 178/2002, provided that applicants are able to prove that the disclosure of certain information would in all certainty be detrimental to their business interests.
Amendment 162 #
Proposal for a regulation
Recital 33
Recital 33
(33) Furthermore, in order to assess the effectiveness and efficiency of the different provisions applying to the Authority, it is also appropriate to provide for a Commission evaluation of the Authority by the Commission, the Member States and their national health authorityies, in accordance with the Common Approach on Decentralised Agencies. The evaluation should, in particular, review the procedures for selecting the members of Scientific Committee and Panels, for their degree of transparency, cost-effectiveness, and suitability to ensure independence and competence, and to prevent conflicts of interests.
Amendment 212 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Directive No 2001/110/EC
Article 2 – paragraph 4 – point a
Article 2 – paragraph 4 – point a
Article 4 a Amendments to Directive (EC) No 2001/110 on honey Directive (EC) No 2001/110 is amended as follows: (1) Article 2 is amended as follows: (a) Article 2, paragraph (4) point a) is replaced by the following text: “The country or countries of origin where the honey has been harvested shall be indicated on the label by which country or countries the honey used in the final product come from, and that these shall be listed in the order which corresponds to the percentage proportions used in the final product additionally stating the percentage by country in a given product.” (b) Article 2 is completed by the following paragraph (6): “The use of the word ‘honey’ or the terms ‘containing honey’ or ‘made with honey’ in the designation of processed food products, or in any graphic or non- graphic element indicating that the product contains honey may only be used if at least 50 % of the sugar- content of the product originates from honey.”