Explanatory Memorandum to COM(2007)194 - Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2007)194 - Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal ... |
|---|---|
| source | COM(2007)194  |
| date | 17-04-2007 |
- Grounds for and objectives of the proposal
The general policy objective is to continue to limit consumer exposure to pharmacologically active substances intended to be used in veterinary medicinal products for food producing animals and residues thereof in foodstuffs of animal origin through Community procedures. Nevertheless the proposal should ensure maintenance of a high level of consumer health protection while not compromising availability of veterinary medicinal products in the Community. At the same time, the proposal should contribute to simplification of legislation by improving the readability and clarity of the Regulation in line with the better regulation strategy of the Commission.
In order to achieve the aim pursued, the following specific objectives have to be born in mind:
- Improve availability of veterinary medicinal products for food producing animals in order to ensure animal health and welfare and avoid illegal use of substances;
- Simplify the existing legislation by enhancing readability of the provisions on established MRLs for the end-users (i.e. animal health professionals, control competent authorities in Member states and third countries);
- Provide clear references for the control of residues of pharmacologically active substances in foodstuffs to improve consumer health protection and the functioning of the Single Market;
- Clarify the Community procedures establishing Maximum Residues Limits (MRLs) by ensuring consistency with international standards.
- General context
The current legal framework for MRLs has lead to particular problems:
1. Availability of veterinary medicines has decreased to an extent that creates adverse effects for public and animal health and animal welfare.
2. International standards supported by the EU cannot be included in Community legislation without a new scientific assessment by the European Medicines Agency.
3. Control services of Member States have no points of reference in particular for substances detected in food from third countries.
4. The current legislation is difficult to understand.
In the absence of a change of existing legislation, a further deterioration of the availability of veterinary medicinal products can be expected with a negative impact on human health, animal health and animal welfare. Furthermore, the negative impact on the animal health industry and food industry would be increased over time.
- Existing provisions in the area of the proposal
Regulation (EEC) No 2377/90
The main changes proposed are the following:
- make the assessment of possibilities for extrapolation a compulsory part of the overall scientific assessment and create a legal basis for the Commission to lay down the principles for applying extrapolation;
- introduce an obligation to adapt Community legislation to include MRLs set by Codex with the support of the EU;
- create a specific legal framework to set maximum residue limits for pharmacologically active substances not intended to be authorised as veterinary medicines in particular for control purposes and for imported food;
- Consistency with the other policies and objectives of the Union
Not applicable.
- Consultation of interested parties
Consultation methods, main sectors targeted and general profile of respondents
The Commission published a Reflection Paper in December 2003 requesting comments on the various points raised for the reconsideration and modification of the Community legislation concerning residues of veterinary medicinal products. This paper analysed the reasons for the difficulties encountered in the application of the existing legislation and sought to propose alternative ways to achieve a high level of consumer protection coupled with continued availability and development of veterinary medicinal products for the European market and good functioning of the intra- and extra Community trade in food of animal origin. Comments on ten main questions were solicited in the Reflection Paper.
The Reflection Paper was published on the websites of Directorate General Enterprises and Industry and Directorate General Health and Consumer Protection of the European Commission.
Two Member States meetings took place on 13 December 2004 and 11 July 2005. At the meeting on 13 December 2004 on the follow-up of the Reflection Paper on residues in food conceptual ideas for legislative amendments were discussed and it was agreed to continue the discussion in six expert Working Groups during spring 2005.
At the meeting with the Member States on 11 July 2005, proposals for changes in the legislation on residues of pharmacologically active substances used in food producing animals identified by the six Working Groups were presented in a Discussion Paper for discussion with Member States representatives.
European bodies which sent comments on the Reflection Paper on residues in food were invited to a meeting on 18th July 2005. Twenty one European organizations attended the meeting. Proposals for changes in the legislation on residues of pharmacologically active substances used in food producing animals identified by six Working Group of Member States' experts were presented in the same Discussion Paper than the one presented to the Member States representatives.
In order to assess the impact of the different possible options, the Commission consulted stakeholders with questionnaires. They were requested to complete a specific questionnaire ranking the different potential solutions identified by the six expert working Groups. The questionnaire was sent to the working groups' experts and to professional organizations' representatives. They were asked to provide their assessment on the key areas of interest.
The impacts were evaluated with a distinction between a positive or a negative impact. A semi-quantitative assessment was provided.212
Summary of responses and how they have been taken into account
Public consultation on the Reflection Paper closed end of March 2003. Comments were received from over 40 sources including 12 Member States, the European Medicines Agency, one European association for the veterinary profession, the pharmaceutical animal health industry and its European asssociation, the organisations of primary producers of foodstuff of animal origin, umbrella organisations of the European food industry as well as European organisations for particular types of food production (dairy, meat and sausages, fish, honey, dried fruit, nuts and spices), two countries outside the EU and a few individual persons.
The meetings with Member States' experts and stakeholders on the Discussion Paper resulted in important guidance for the Commission on major items. The main ideas of this consultation were taken on board by the Commission in the drafting of the legal proposal. The semi-quantitative assessment based on stakelholders interviews was used for the impact assessment.213
An open consultation was conducted over the internet from 18/12/2003 to 20/03/2004. The Commission received 40 response(s). The results are available on europa.eu.int/common/entreprise/pharmaceuticals 2004.htm.
- Collection and use of expertise
There was no need for external expertise.230
- Impact assessment
- Option 1 - To maintain the current legal framework. Maintaining the current legal framework would mean that existing availability problems would be unresolved. The existing practice of only limited use of extrapolation one residue limit to different tissues and species would continue. Consistency with international standards could not be promoted as the current legislation requires new scientific assessment. Moreover, the lack of harmonisation in the area of control would persist with different control levels of Member States without a clear scientific basis. The general lack of clarity of the legislation would not be overcome and risks of erroneous application would continue.
- Option 2 - To review the existing regulation by incorporating specific legal provisions and amending existing rules to address the specific objectives. A review provides the chance to overcome the existing shortage of veterinary medicines in the medium and long term by establishing a clear legal basis for extended use of one residue limit for other tissues and species. International standards supported by the European Union could directly be incorporated in European Union legislation. Furthermore, the food industry and third countries would be provided with a clear science-based European Union reference for residues of substances not intended for use in veterinary medicines in the Community. Finally, improved clarity could be achieved with the review of the legislation, in particular by creating one consolidated list of substances with their different classifications. This should result in improved compliance. Overall the administrative burden would be reduced.
- Option 3 - To replace the existing legislation by guidelines. The option of replacing the existing legislation by guidelines would create public health risks Deregulation of the internal market and different levels of food safety could lead to crisis in consumer confidence with major economic losses. Self-regulation would result in a reduced administrative burden, but this effect would be offset by enforcement mechanisms to be created under such system.
Contents
- Summary of the proposed action
The legal proposal addresses the shortcomings of the current situation by amending on substance the existing legal framework on maximum residue limits while leaving the overall system of setting maximum residue limits based on scientific assessment intact. The main changes proposed are the following:
- make the assessment of possibilies for extrapolation a compulsory part of the overall scientific assessment and create a legal basis for the Commission to lay down the principles for applying extrapolation;
- introduce an obligation to adapt Community legislation to include MRLs set by Codex with the support of the EU;
- create a specific legal framework to set maximum residue limits for pharmacologically active substances not intended to be authorised as veterinary medicines in particular for control purposes and for imported food;
- rearrange the sequence of articles in order to create a logical structure, differentiating in particular risk assessment and risk management provisions;
- integrate in a separate Commission regulation the rules (MRLs, conditions of use, prohibitions) relating to individual substances, which are currently in 4 annexes of the current basic act.
- Legal basis
Article 37, Article 152 i (b) of the Treaty329
- Subsidiarity principle
The proposal falls under the exclusive competence of the Community. The subsidiarity principle therefore does not apply.
- Proportionality principle
The proposal complies with the proportionality principle for the following reason(s).
The setting of residue limits is an integral part of the Community system of authorisations for veterinary medicinal product and of food controls in the EU. While controls are carried out by Member States, there is no choice than fixing the same residue limits for the benefit of the free circulation of goods in the EU.
The objective is to reduce the administrative burden for economic operators compared with the burden caused by the existing legal framework.
The administrative burden would be reduced by three factors:
- the absence of the need for a separate scientific assessment of active substances which have been assessed by Codex. The reduction would result on the one hand from the non-delivery of a full file including all requested data and on the other hand from the speeding-up of the process of authorising the veterinary medicine in question.
- the reduction of scientific data to be provided, if the scientific committee extends the application of extrapolation. Actually, as the new regulation would require the committee to consider extrapolation and to balance their decision on setting maximum residue limits with the need to ensure availability of medicines, broader use of extrapolation can be expected.
- The harmonisation of control standards for certain residues in food. Industry currently faces an unjustified burden by divergent control reference points in different Member States. The benefits of the common market can not be fully realised for this reason and also imports from third countries face unnecessary obstacles. Refusal of consignments or even destruction of goods cause drastic economic consequences for producers and traders, which could be avoided to a large extent with one single transparent reference point applied by competent authorities in all Member States.
- Choice of instruments
Proposed instruments: regulation.342
Other means would not be adequate for the following reason(s).
Self regulation would result in the total deregulation of the single market and most probably major discrepancies in veterinary medicinal products availability as well as discrepancies in level of safety of food of animal origin within the Community. Consumer confidence on meat and meat products is currently built on a single harmonised set of rules applied under the strict supervision of competent authorities. Self regulation could not assure a comparable level of harmonisation and enforcement. Clearly, risks for consumer health would increase as a result of self regulation because there would be no comparable enforcement mechanism available ensuring the respect of adequate residue limits.
A directive would not be adequate, because the residue limits are directly applicable. Furthermore, uniform administrative or scientific procedures have to apply for the applications for setting residue limits to the European Medicines Agency (EMEA), scientific assessments by the EMEA and the scientific opinions issued by the EMEA.
409The proposal has no implication for the Community budget.
- Simplification
511The proposal provides for simplification of legislation.
- to rearrange the sequence of articles in order to create a logical structure, differentiating in particular risk assessment and risk management provisions;
- integrate in one single annex of a separate Commission regulation the rules (MRLs, conditions of use, prohibitions) relating to individual substances, which are currently in 4 different annexes.
- the public authorities profit from the improved readibility of the residue legislation. In particular the consolidation in one single regulation of all residue limits makes the work of enforcement by control authorities easier.
- timelines for procedural management would be clearly fixed for all parties involved. International standards supported by the Community would be automatically recognised without the need to submit any specific application at Community level, and thus avoiding duplication of work. The development time and cost for new products should be accordingly reduced. Animal health and welfare and consumer health shall benefit significantly by making legislation clearer and thus potentially improving compliance with legislative requirements.
- furthermore, the review of the MRL Regulation would also introduce more transparency for all end users. The compilation of all substances and their MRL related provisions in one Commission regulation replacing the existing four annexes would improve the readability and comprehension, in particular if sorted to the alphabet. Veterinarians should have access to a unique document collating all the necessary information on all substances evaluated as they are allowed to use in exceptional circumstances products for a food producing species without an explicit authorisation of this product (article 11 of Directive 2001/82/EC). Thereby simplification would help to improve availability of veterinary medicine for certain animal species or conditions. Equally third countries exporting foodstuffs of animal origin in the Community would benefit from that simplification and clarification of the Community requirements as compliance should get easier.
- The proposal is included in the Commission's rolling programme for up-date and simplification of the acquis communautaire.
- Repeal of existing legislation
The adoption of the proposal will lead to the repeal of existing legislation.
- Recasting
The proposal involves recasting.
- European Economic Area
The proposed act concerns an EEA matter and should therefore extend to the European Economic Area.