Activites

• 2009/06/16 Final act published in Official Journal
  • Regulation 2009/470
  • OJ L 152 16.06.2009, p. 0011
• 2009/05/06 Final act signed
• 2009/05/06 End of procedure in Parliament
• 2009/04/02 Results of vote in Parliament
  • Results of vote in Parliament
  • T6-0206/2009 summary

    The European Parliament adopted a legislative resolution approving unamended, under the second reading of the codecision procedure, the Council’s common position with a view to the adoption of a regulation of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin and repealing Council Regulation (EEC) No 2377/90.

• 2009/04/01 Debate in Parliament
  • Debate in Parliament
• 2009/02/12 Committee recommendation tabled for plenary, 2nd reading
  • A6-0048/2009
• 2009/02/10 Vote in committee, 2nd reading
• 2009/01/15 Committee referral announced in Parliament, 2nd reading
• #2917
• 2008/12/18 Council Meeting
  • 15079/2/2008 summary

    The Council's common position confirms the objectives and most of the arrangements proposed by the Commission and includes, in part or in their entirety 34 amendments passed at first reading by the European Parliament.The Council introduced the following amendments to the Commission proposal:Improvement of the availability of veterinary medicinal products: at the suggestion of the Parliament, amendments were made to a few provisions in order to try to improve the availability of veterinary medicinal products for food producing animals, in particular with regard to minor species and minor uses. More specifically, the Council wanted to clarify the cases in which Member States and the Commission may ask an opinion on MRLs to the Agency. In addition, the Council judged preferable to add provisions on the modalities of financing of MRL evaluations for active substances included in biocidal products. Furthermore, the Council recalled the importance of ensuring a high degree of human health protection and made some changes to insist on this aspect.Establishment/review and functioning of reference points for action: following a series of Parliament amendments, several provisions were adapted to clarify the Commission proposal regarding in particular the definition of reference points for action and conditions for their establishment and review. Further, the conditions for placing food of animal origin on the market were specified. Likewise the measures to be taken when a forbidden or non authorised substance is found were defined.Report to European Parliament and the Council: the Council also followed Parliament in asking the Commission to present a report on the experience gained from the application of the regulation, not later than 5 years after its entry into force. In addition, the Council requested that the report considers in particular substances classified under the regulation and having a multiple use.The Council, like the Commission, could not accept 5 amendments. Contrary to the Parliament the Council deemed essential to maintain a double legal basis as the proposal is relevant to the functioning of the internal market for products of animal origin included in Annex I to the Treaty. Moreover, the Council could not accept the comitology procedure with scrutiny considering the fixing of MRLs for specific substances to be a purely implementing measure with no quasi-legislative character. Lastly, the Council could not accept the complete deletion of the free circulation clause.

• 2008/06/17 Decision by Parliament, 1st reading/single reading
  • T6-0285/2008 summary

    The European Parliament adopted by 660 votes to 13 with 5 abstentions, a legislative resolution amending the proposal for a regulation of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, and repealing Regulation (EEC) No 2377/90. The report had been tabled for consideration in plenary by Avril DOYLE (EPP-ED, IE) on behalf of the Committee on the Environment, Public Health and Food Safety.The amendments - adopted under 1st reading of the codecision procedure – are as follows:-purpose: Parliament emphasises the general purpose of this Regulation, which is that of ensuring food safety;-reference points for action: this is now defined as the level of a residue of a pharmacologically active substance, established for control reasons in the case of certain substances for which a maximum residue limit has not been laid down in accordance with this Regulation. In addition, Parliament introduced a new Article on implementing reference points for action. The reference points for action shall be reviewed in the light of any new data concerning the protection of human health and the food chain;-European Food Safety Authority: the risk management recommendations should take into account any relevant scientific findings of the European Food Safety Authority, by way of letters of cooperation;-scientific risk assessment: the principles of risk assessment pursuant to Articles 4 to 8 shall be applied in order to guarantee a high level of health protection.-toxicological, as well as pharmacological or microbiological effects in human beings should be considered;-equidae: a new clause states that veterinary medicinal products which do not have a maximum residue limit for equidae, which are not included in Annex IV of Regulation (EEC) No 2377/90 or in Article 13(2) of this Regulation, and which are used "off-label", as defined in Article 1(16) of Directive 2001/82/EC, and "under the provisions of the cascade" and not administered intra-muscularly or subcutaneously, shall have a nominal withdrawal period of six months. Furthermore, the use of pharmaceuticals containing pharmacologically active ingredients not on "the essential" substances list or the "positive list" for equidae referred to in Article 10(3) of Directive 2001/82/EC and not administered intra-muscularly or subcutaneously, shall have a nominal withdrawal period of six months; -urgent authorisation: in specific cases where urgent authorisation is required to ensure the protection of human health and animal health and welfare, the Commission may, in accordance with the regulatory procedure with scrutiny, establish a provisional maximum residue limit for a period not exceeding five years;-requests for an opinion on maximum residue limits: the proposal had stated that the Commission or Member States may forward to the Agency requests for an opinion for substances not intended for use in veterinary medicinal products to be placed on the market in the Community and where no application for such substances has been made. Parliament introduced wording which states that the Commission, Member States or a third party pursuing legitimate interests may forward to the Agency requests for an opinion on MRLs for pharmacologically active substances in certain circumstances which are prescribed in the text;-comitology: defining the methodology of the risk assessment and of risk management will be done in accordance with the regulatory procedure with scrutiny. Moreover, Parliament altered the time limits for the adoption of decisions;-accelerated procedure for an Agency opinion: a new clause states that, in specific cases where a veterinary medicinal product or a biocidal product needs to be authorised as a matter of urgency for reasons relating to the protection of public health or of animal health or welfare, the Commission, any person who has requested an opinion, or a Member State may ask the Agency to carry out an accelerated procedure for the assessment of the maximum residue limit of a pharmacologically active substance contained in those products. The Agency shall ensure that the Committee is able to issue its opinion within 150 days following receipt of the application;-placing on the market: a new Article states that if the maximum residue limits or reference quantities established under this Regulation are exceeded, the product shall not be placed on the market as a foodstuff, transformed into foodstuffs or mixed with foodstuffs.Foodstuffs of animal origin containing pharmacologically active substances for which no maximum residue limits have been set may not be placed on the market;-import: Member States shall prohibit the import and placing on the market of food of animal origin containing residues resulting from the illegal administration of pharmacologically active substances which are not subject to a classification in accordance with the text. Accordingly, imports from third countries of food containing residues resulting from the illegal administration of substances whose use is use is banned within the European Union shall be prohibited in the interests of public health;-report: the Commission shall, not later than five years after the entry into force of the Regulation, submit a report which will, in particular, review the experience gained from the application of the Regulation, and, if appropriate, be accompanied by proposals.

• 2008/05/16 Committee report tabled for plenary, 1st reading/single reading
  • A6-0190/2008
• 2008/05/06 Vote in committee, 1st reading/single reading
• 2007/05/24 Committee referral announced in Parliament, 1st reading/single reading
• 2007/04/17 Legislative proposal published
  • COM(2007)0194 summary

    PURPOSE: to apply new procedures for establishing residue limits of pharmacologically active substances in foodstuffs of animal origin.PROPOSED ACT: Regulation of the European Parliament and of the Council.BACKGROUND: Council Regulation (EEC) No 2377/90 lays down the Community procedure for establishing the maximum residue limits (MRLs) of veterinary medicinal products in foodstuffs of animal origin. However, the current legal framework for MRLs has led to a number of problems. For example, the availability of veterinary medicines has decreased to such an extent that it has created adverse effects on public and animal health as well as on animal welfare. Also, international standards (that have the support of the EU) can not be included into EU legislation without a new scientific assessment by the European Medicines Agency. Control services of Member State haves no points of reference for substances detected in food from third countries and, lastly, the current legislation is intransparent and hence difficult to understand.CONTENT: the purpose of this proposal, therefore, is to address the shortcomings of the current situation by amending, on substance, the existing legal framework relating specifically to MRLs whilst, at the same time, leaving the overall system of setting maximum residue limits based on scientific assessment intact. In brief the main changes being proposed are as follows:-          to make the assessment of possibilities for extrapolation a compulsory part of the overall scientific assessment and to create a legal  basis for the Commission to lay down the principles for applying extrapolation;-          to introduce an obligation to adapt Community legislation to include MRLs set by Codex with the support of the EU;-          to create a specific legal framework and to set MRLs for pharmacologically active substances not intended to be authorised as veterinary medicines in particular for control and purpose and for imported food;-          to rearrange the sequence of articles in order to create a logical structure, differentiating in particular risk assessment and risk management provisions; and-          to integrate, in a separate Commission Regulation, the rules (MRLs, conditions of use, prohibition etc.) relating to individual substances, which can currently be found in 4 annexes of the current basic act.The proposal provides for significant improvements in terms of simplification – i.e. the restructuring of the Articles and the integration into a single Annex of all the rules concerning MRLs, conditions of use, prohibition etc. The public authorities, in particular, will benefit from the improved readability of the residue legislation. Consolidating, into one single Regulation all residue limits will make the work of enforcement by control authorities much easier. Further, the timelines for procedural management will be clearly fixed for all parties. International standards supported by the Community would be automatically recognised without the need to submit any specific application at Community level – thereby avoiding duplication of work.In addition, veterinarians will have access to a single document in which all relevant information is collated. It will include data on all substances evaluated. Similarly, third countries exporting foodstuffs of animal origin into the Community will benefit from further simplification and the clarification of Community requirement.As far as the budget is concerned the proposal will have no impact on the Community budget but could have a negligible (or even no) cost on the European Medicines Agency (EMEA). The proposed Regulation’s financial impact on revenues is uncertain. An increase in applications for authorisations of veterinary medicinal products could lead to an increase of fee revenues for the EMEA. As far as expenditure is concerned, the proposal will not change the principle whereby the system of residue limits is operated by the EMEA and the Commission. Additional scientific assessments will be required for residue limits for control purposes while less assessments will result from the taking over of limits set by Codex alimentarius and from extrapolation requirements. In overall terms the review will thus have a very limited impact on resources which can not be quantified.

  • DG {'url': 'http://ec.europa.eu/enterprise/', 'title': 'Enterprise and Industry'}, VERHEUGEN Günter

Documents

• Legislative proposal published: COM(2007)0194
• Committee report tabled for plenary, 1st reading/single reading: A6-0190/2008
• Decision by Parliament, 1st reading/single reading: T6-0285/2008
• Council position published: 15079/2/2008
• Committee recommendation tabled for plenary, 2nd reading: A6-0048/2009
• Debate in Parliament: Debate in Parliament
• Results of vote in Parliament: Results of vote in Parliament
• Decision by Parliament, 2nd reading: T6-0206/2009
• : Regulation 2009/470
• : OJ L 152 16.06.2009, p. 0011

History

(these mark the time of scraping, not the official date of the change)