Explanatory Memorandum to COM(2002)153 - Additives for use in animal nutrition - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2002)153 - Additives for use in animal nutrition. |
|---|---|
| source | COM(2002)153  |
| date | 22-03-2002 |
With a view to bringing coherence to Community legislation in a 'farm to table' approach, the Commission announced in the White Paper on Food Safety that it would propose legislation to consolidate existing rules on additives in feedingstuffs and clarify certain procedural aspects related to dossier evaluation and the types of authorisation granted to feed additives (Action 19 in the White Paper).
So far, the basic legislation (Council Directive 70/524/EEC) has undergone five major amendments and numerous modifications of the annexes (over 100). The Directive has never been consolidated.
The current legislation is rather complex. The existence of different types of authorisation (provisional, for ten years or with no time limit, linked to the applicant company or not) complicates the implementation of EC rules on this matter.
In certain cases, Member States may derogate from the common provisions (e.g. additive levels in complementary feedingstuffs, incorporation rates for additives and premixtures in feedingstuffs). The consequence is that different interpretations are possible, and enforcement of certain decisions adopted at EC level becomes ineffective.
The procedure for dossier evaluation involves two Committees: the Standing Committee for Feedingstuffs, made up of representatives of the Member States ("comitology" procedure), and the Scientific Committee for Animal Nutrition (SCAN).
The current procedure for authorising new additives or new uses of additives can be described as follows:
- the applicant company selects a Member State to act as rapporteur. When the applicant is established in a third country, he must have a representative in the Community;
- the Member State acting as rapporteur checks that the application dossier contains all the information required;
- the Member State acting as rapporteur dispatches copies of the dossier to the Commission and to the other Member States;
- Member States have a period of sixty days to check whether the dossier has been compiled in accordance with EC rules;
- if no objections are made by the Member States, the Commission has a period of thirty days to include the application for authorisation on the agenda of the Standing Committee;
- the Commission ensures that a decision on the application for Community authorisation is taken within 320 days following its inclusion on the agenda of the Standing Committee.
During this procedure, the SCAN is usually asked for an opinion. The time limit is suspended if members of the Standing Committee or the SCAN request additional information.
This arrangement does not provide for a clear separation between risk evaluation and risk management as the Standing Committee also deals with risk management. Furthermore, this methodology relies heavily on the work of the Member State acting as rapporteur. In certain cases, rapporteur Member States are not neutral and behave as ardent defenders of the applicant company.
The whole procedure is time-consuming and rather confusing for the applicant companies, which sometimes receive similar questions from different bodies (members of the Standing Committee and the SCAN).
Contents
This proposal covers the incorporation of the additive in feedingstuffs and in drinking water. The emergence of new products and new feeding techniques, as well as the need to consider the use of additives in silage, are elements that must be taken into account.
A real demonstration of the positive effect of the additive (on the feedingstuff or on the animal) is also a key element. On the other hand, only those feed additives may be authorised which do not present any risk for human health, animal health or the environment.
The European Food Safety Authority (EFSA) will have the competence and the responsibility to provide a single framework for dossier evaluation for all feed additives, and will bring clarity (guidelines will be updated and adapted to the various types of additives), efficiency (a single evaluation) and transparency (adoption of an assessment report and public consultation) to the process.
A definition of feed additives is provided by this Regulation. Processing aids and veterinary medicines are not covered within the scope of this regulation.
Only additives that are safe for humans, animals and the environment, and do not mislead the user or impair distinctive features of animal products, will be authorised.
Only additives covered by an authorisation under this Regulation will be allowed to be put on the market, used or processed.
For some well defined categories of additives, no person other than the authorisation holder shall put the additive on the market. The reason for this is the need to identify the person responsible for the supervision requirements to be met during the authorisation period.
General rules concerning the incorporation of additives in feedingstuffs and, in particular, minimum incorporation rates, are not provided for in the proposal. Likewise, labelling provisions concerning feedingstuffs are not considered in this proposed Regulation and are left to the relevant legislation.
Processing aids, which are only used during the feed production process to achieve a certain technological objective, need to be addressed separately and therefore these products fall outside the scope of this Regulation.
In absence of an equivalent level of harmonisation between Regulation (EEC) 2309/93 concerning the authorisation and surveillance procedure of medicinal products, Directive 90/167/EEC on the preparation and placing on the market of medicated feed, and of Directive 70/524/EEC, the borderline between veterinary medicinal products and feed additives is clarified. Except for coccidiostats fed to healthy animals during their entire productive life, compounds used in disease prevention, namely antibiotics, are not authorised as feed additives.
The use of coccidiostats as feed additives will thus continue to be permitted but Maximum Residue Limits (MRLs) will be fixed in order to avoid risks to human or animal health. Under the current European system of intensive husbandry, the treatment of farmed animals, in particular poultry, by coccidiostats is, according to operators, indispensable. Therefore, if such substances could not be administered as additives, they would in any case be administered as medicated feed, with a possible increase of cost and an increase of doses. However, the maintaining of the status of coccidiostats as feed additives requires that a new evaluation of these substances takes place in a maximum delay of four years after the entry into force of this Regulation.
In order to clarify the structure of the list of authorised additives, this list will be divided into a restricted number of broad additive categories:
- technological additives (e.g. preservatives);
- sensory additives (e.g. flavours, colorants);
- nutritional additives (e.g. vitamins);
- zootechnical additives (e.g. gut flora improvers, non-microbial growth promoters);
- coccidiostats.
Each category is further divided into functional groups. Sufficient flexibility must be provided within each category to allow for the emergence of new groups of products, in order to adapt the list to new developments in science or technology.
Unless otherwise specified, the mixing of authorised additives will be allowed. Consequently, mixtures of authorised additives should not be subject to specific authorisations.
Following concerns raised by the international scientific community, the authorisations of the following antibiotic feed additives were withdrawn: avoparcin, tylosin phosphate, spiramycin, virginiamycin and bacitracin zinc (Commission Directive 97/6/EC of 30 January 1997 and Council Regulation (EC) No 2821/98 of 17 December 1998 respectively).
The reason is the potential risk of transfer of antimicrobial resistance from microorganisms of livestock origin to human pathogens.
In its opinion adopted on 28 May 1999, the Scientific Steering Committee (SSC) recommended that the use of antimicrobials as growth promoting agents, belonging to classes that are or may be used in human or veterinary medicine, should be phased out as soon as possible and ultimately abolished.
A second opinion of the SSC on anti-microbial resistance adopted on 10-11 May 2001 confirmed the need to plan and co-ordinate the phase-out process and to make efforts to replace those antimicrobials by alternative products.
In order to comply with the SSC recommendation, the following steps are now being taken:
- exclusion of the antibiotics from the scope of the new legislation on feed additives, i.e. the request for authorisation of antibiotic feed additives will no longer be permitted;
- adoption of a transitional period for the phasing out of the four remaining antibiotics in order to allow animal production practices to be adapted. These substances will be prohibited from 1.1.2006.
The principle of a positive list is maintained: only the additives listed in a register are allowed to be placed on the market, used or processed, subject to particular conditions of use if necessary (dose, animal categories, etc.).
The list will be made available to all interested parties.
In summary, the procedure laid down in the proposed Regulation is as follows:
- the person responsible for placing the additive on the market will submit an application to the European Food Safety Authority (EFSA);
- the Authority will give an opinion within 6 months;
- the Authority will forward its opinion to the Commission, the Member States and the applicant, and make its opinion public as soon as possible after adoption. Following publication of the opinion, the public may make comments to the Commission;
- the Commission will prepare a draft Regulation within three months of receipt of the opinion of the EFSA. In the event of a Regulation granting an authorisation of an additive, this will be entered in the register.
The authorisation will be valid for ten years.
Existing authorised products will be dealt with, in summary, as follows:
- within one year of the entry into force of the Regulation, the person responsible for placing an authorised additive on the market will notify the Authority of this fact;
- within one year of the notification and after verification that the required information has been submitted, the Authority will notify the Commission to this effect and the additive will be entered in a register;
- at the latest one year before the expiry date of the authorisation (for additives with a limited authorisation period), or within seven years after the entry into force of the Regulation (for additives authorised without a time limit), an application for authorisation will be submitted. However, for coccidiostats an application must be submitted within four years of the entry into force of the Regulation.
Authorisations will be renewable for ten-year periods upon application to the Authority at least one year before the expiry date.
Unless the applicant demonstrates it is not necessary, the scientific assessment shall be supplemented by residues studies to be submitted by the applicant. In this case the opinion of the Authority shall include a proposal for the setting of maximum residues levels (MRLs). The Regulation according the authorisation of the feed additive shall fix MRLs for the active substance.
Additives that are either genetically modified or produced from a GMO should first comply with the requirements of and be evaluated according to the Regulation on genetically modified food and feed, prior to undergoing the authorisation procedure under this proposed Regulation.
After the authorisation of a feed additive has been granted, the authorisation holder has obligations in respect to the supervision of conditions of marketing of the additive. The authorisation holder must communicate to the Authority any new information concerning the safety of the product, in particular possible effects on particular health sensitivities of specific categories of consumers.
The following particulars will be required for the labelling of all additives:
- the name of the additive, as mentioned in the register;
- the name and address of the person responsible for placing the product on the market;
- the net weight of the active component;
- directions for use and safety recommendations.
For certain categories of additives, the expiry date and specific references (such as the targeted animal category) may also be required.
The labelling will also indicate whether the additive is intended to be incorporated in feedingstuffs or in drinking water.
Implementation of the measures proposed in the Regulation, and adaptation of the dossier requirements to new developments in scientific and technical knowledge, will be decided on by the Commission in accordance with the regulatory procedure laid down in Council Decision 1999/468/EC.
Scientific data and other information in the initial dossier submitted for the purpose of authorisation may not be used for the benefit of other applicants for a period of ten years, unless the applicant has agreed that such information may be used.