CELEX: 52001PC0498
Language: en
Date: 2001-09-04
Title: Proposal for a Council Regulation amending Council Regulation (EC) No 1587/98 of 17 July 1998 introducing a scheme to compensate for the additional costs incurred in the marketing of certain fishery products from the Azores, Madeira, the Canary Islands and the French departments of Guyana and Réunion as a result of those regions' remoteness

C 332 E/242            EN                       Official Journal of the European Communities                                    27.11.2001
               Proposal for a Council Directive amending Council Directive 1999/29/EC on the undesirable
                                              substances and products in animal nutrition
                                                              (2001/C 332 E/06)
                                                             COM(2001) 493 final
                                             (Submitted by the Commission on 28 August 2001)
THE COUNCIL OF THE EUROPEAN UNION,                                              the toxicity of these different congeners, the concept of
                                                                                toxic equivalency factors (TEFs) has been introduced to
                                                                                facilitate risk assessment and regulatory control. This
                                                                                means that the analytical results relating to all 17 indi-
Having regard to the Treaty establishing the European                           vidual dioxin congeners and to the 12 dioxin-like PCB
Community,                                                                      congeners are expressed in terms of a single quantifiable
                                                                                unit: TCDD toxic equivalent concentration (TEQ).
Having regard to Council Directive 1999/29/EC of 22 April
1999 on the undesirable substances and products in animal
nutrition (1), and in particular Article 10 point (a) thereof,
                                                                            (5) Dioxins and PCBs are extremely resistant to chemical and
                                                                                biological degradation and therefore persist in the
Having regard to the proposal from the Commission,                              environment and accumulate in the feed and food chain.
Whereas:
                                                                            (6) The distribution of dioxins, PCBs and dioxin-like PCBs
  (1) Directive 1999/29/EC provides that that feed materials                    throughout the environment causes background contami-
      may only be put into circulation in the Community if                      nation affecting all terrestrial plants directly grazed or
      they are sound, genuine and of merchantable quality.                      used as feed materials for animal feed as well as the
                                                                                aquatic feed chain. The same applies to the soil that
                                                                                might contaminate feed materials or be directly ingested
  (2) The term dioxins covers a group of 75 polychlorinated                   by animals. In addition to background contamination,
      dibenzo-p-dioxin (PCDD) and 135 polychlorinated diben-                  direct accidental pollution of feed materials may occur
      zofuran (PCDF) congeners, of which 17 are of toxico-                    due to localised discharge of dioxins from industrial
      logical concern. The most toxic congener is                               activities, contamination of feed materials during their
      2,3,7,8-tetrachlordibenzo-p-dioxin (TCDD) classified by                   production, processing and transportation, and illegal
      the International Agency for Research on Cancer and                       practices or management failures during feed production.
      other reputable international organisations as a known
      human carcinogen. The Scientific Committee for Food
      (SCF), in line with the World Health Organisation
      (WHO), concluded that the carcinogenic effect of
      dioxins does not occur at levels below a certain threshold.
      Other adverse effects, such as endometriosis, neurobehav-             (7) More than 90 % of human dioxin exposure derives from
      ioural and immunosuppressive effects occur at much                        foodstuffs. Foodstuffs of animal origin normally contribute
      lower levels and are therefore considered relevant for                    to approximately 80 % of overall exposure. The dioxin
      the determination of a tolerable intake.                                  burden in animals derives mainly from feedingstuffs.
                                                                                Therefore feedingstuffs, and in some cases soil, are of
                                                                                concern as potential sources of dioxins.
  (3) Polychlorinated biphenyls, (PCBs), are a group of 209
      different congeners which can be divided into two
      groups according to their toxicological properties: 12
      congeners exhibit toxicological properties similar to
      dioxins and are therefore often termed dioxin-like PCBs.            (8) The SCF adopted an opinion on the Risk Assessment of
      The other PCBs do not exhibit dioxin-like toxicity but                    Dioxins and Dioxin-like PCBs in Food on 30 May 2001;
      have a different toxicological profile.                                   this is an update based on new scientific information
                                                                                available since the adoption of the SCF opinion on this
                                                                                matter on 22 November 2000. The SCF fixed a tolerable
                                                                                weekly intake (TWI) for dioxins and dioxin-like PCBs of
  (4) Each congener of dioxins or dioxin-like PCBs presents a                   14 pg WHO-TEQ/kg body weight. Exposure estimates
      different level of toxicity. In order to be able to sum up                indicate that a considerable proportion of the
                                                                                Community population has a dietary intake in excess of
(1) OJ L 115, 4.5.1999, p. 32.                                                  the tolerable intake.
 ---pagebreak--- 27.11.2001           EN                       Official Journal of the European Communities                                     C 332 E/243
 (9) The reduction of human exposure to dioxins through food                   ingstuffs, maximum levels should be accompanied by
     consumption is therefore important and necessary to                       measures stimulating an active approach, including
     ensure consumer protection. As food contamination is                      action levels and target levels for feedingstuffs in combi-
     directly related to feed contamination, an integrated                     nation with measures to limit emissions. Target levels
     approach must be adopted to reduce dioxin incidence                       indicate the levels to be achieved in order to ultimately
     throughout the food chain, i.e. from feed materials                       bring human exposure for the majority of the population
     through food-producing animals to humans. The intro-                      down to the TWI set by the SCF. Action levels are a tool
     duction of measures relating to feed materials and feed-                  for competent authorities and operators to identify those
     ingstuffs is therefore a crucial step towards reducing                    cases where it is appropriate to identify a source of
     dioxin intake by humans.                                                  contamination and to take measures for its reduction or
                                                                               elimination, not only in the event of non-compliance with
                                                                               the provisions of this Directive but also where significant
                                                                               levels of dioxins above normal background levels are
                                                                               found. This will result in a gradual reduction of dioxin
(10) The Scientific Committee for Animal Nutrition (SCAN)                    levels in feedingstuffs, and the target levels will ultimately
     has been asked to advise on the sources of contamination                  be achieved. A Recommendation from the Commission
     of feedingstuffs with dioxins and PCBs, including                         on this issue is therefore being addressed to the Member
     dioxin-like PCBs, the exposure of food-producing                          States.
     animals to dioxins and PCBs, the carry-over of these
     compounds to food products of animal origin, and any
     impact on animal health of dioxins and PCBs present in
     feedingstuffs. The SCAN adopted an opinion on 6
     November 2000. It identified fish meal and fish oil as               (14) Although, from a toxicological point of view, any level
     the most heavily contaminated feed materials, with                        should apply to dioxins, furans and dioxin-like PCBs, for
     products of European origin more heavily contaminated.                    the time being the maximum levels are set only for
     Animal fat was identified as the next most seriously                      dioxins and furans and not for dioxin-like PCBs, given
     contaminated material. All other feed materials of                        the very limited data available on the prevalence of the
     animal and plant origin had relatively low levels of                      latter. However, monitoring will continue, in particular on
     dioxin contamination. Roughages presented a wide range                    the presence of dioxin-like PCBs with a view to including
     of dioxin contamination depending on location, degree of                  these substances in the maximum levels.
     contamination with soil and exposure to sources of aerial
     pollution.
                                                                         (15) The unacceptability of the dioxin content of feedingstuffs
                                                                               should be assessed in the light of the current background
(11) Measures should be implemented with the aim of                            levels of contamination, which differ from feed material to
     reducing the presence and release of dioxin contamination                 feed material. The maximum level should be fixed, taking
     of the environment in order to reduce the impact of                       account of background contamination, at a strict but
     environmental pollution on the contamination of feed                      feasible level.
     materials. The SCAN recommended, inter alia, that
     emphasis should be placed on reducing the impact of
     the most contaminated feed materials on overall diet
     contamination.
                                                                          (16) In order to ensure that all operators in the food and feed
                                                                               chain continue to make all possible efforts and do all that
                                                                               is necessary to limit the presence of dioxins in feed and
                                                                               food, the maximum levels applicable should be reviewed
(12) Maximum levels for dioxins and dioxin like PCBs should                    within a defined period with a view to setting lower
     be an appropriate tool to prevent unacceptably high                       maximum levels. An overall reduction of at least 25 %
     exposure of animals and to prevent the distribution of                    in human exposure to dioxins should be achieved by
     feedingstuffs with an unacceptably high level of contami-                 2006.
     nation, e.g. in cases of accidental pollution and exposure.
     Furthermore the setting of maximum levels is indis-
     pensable for the implementation of a regulatory control
     system and to ensure uniform application.
                                                                          (17) Compound feedingstuffs and feed materials of plant origin
                                                                               do not normally contain high levels of dioxins. Since feed
                                                                               materials of plant origin are by far the largest component
                                                                               in the diet of many species of animals, it is appropriate to
(13) Measures based solely on establishing maximum levels for                  set a maximum level also for these feed materials. The
     dioxins and dioxin-like PCBs in feedingstuffs would not be                more sensitive the method of analysis, the more expensive
     sufficiently effective in reducing human exposure to                      and time-consuming the analysis to check for dioxin. As it
     dioxins unless the levels were set so low that a large                    is important that as many samples as possible be analysed,
     part of the feed supply would have to be declared unfit                   the maximum levels proposed are somewhat higher than
     for animal consumption. It is generally recognised that, in               normal background levels given that they constitute
     order to actively reduce the presence of dioxins in feed-                 upperbound levels.
 ---pagebreak--- C 332 E/244           EN                     Official Journal of the European Communities                                      27.11.2001
(18) Certain clays authorised for use as binders, anti-caking           These provisions shall be reviewed for the first time by 31
      agents and coagulants have been found to be                       December 2004 at the latest in the light of new data on the
      contaminated by dioxins or, in some cases, it cannot be           presence of dioxins and dioxin-like PCBs, in particular with a
      ruled out that they may be contaminated. Trace elements           view to the inclusion of dioxin-like PCBs in the levels to be set.
      such as zinc oxide and copper oxide have also been found
      to be contaminated with dioxins. It is appropriate for
      these additives to be subject to a maximum level in line          These provisions shall be further reviewed by 31 December
      with that applying to maximum level established for               2006 at the latest with the aim of significantly reducing the
      minerals. However, since maximum levels of undesirable            maximum levels.
      substances in additives do not fall within the scope of
      Council Directive 1999/29/EC, a maximum level should
      be set within the framework of Directive 70/524/EEC of                                        Article 2
      23 November 1970 concerning additives in feed-
      ingstuffs (1).                                                    1.    Member States shall adopt and publish, before 1 January
                                                                        2002 the laws, regulations and administrative provisions
                                                                        necessary to comply with this Directive. They shall forthwith
(19) It is of utmost importance to reduce that overall levels of        inform the Commission thereof. They shall apply these
      dioxin contamination in feedingstuffs be reduced. It is           provisions from 1 January 2002.
      therefore absolutely necessary to prohibit the mixing of
      feed materials and feedingstuffs complying with the
      maximum levels with feed materials/feedingstuffs                  2.    When the Member States adopt those provisions, they
      exceeding these maximum levels.                                   shall contain a reference to this Directive or be accompanied
                                                                        by such a reference on the occasion of their official publication.
                                                                        Member States shall determine how such reference is to be
(20) Directive 1999/29/EC should therefore be amended                   made.
      accordingly.
                                                                        3.    Member States shall communicate to the Commission the
(21) The Standing Committee for Feedingstuffs did not deliver           texts of the provisions of national law, which they adopt in the
      a favourable opinion. The Commission has been therefore           field covered by this Directive.
      unable to adopt the provisions it envisaged according to
      the procedure laid down in Article 13 of Council Directive
      1999/29/EC of 22 April 1999,                                                                  Article 3
                                                                        This Directive shall enter into force on the twentieth day
HAS ADOPTED THIS DIRECTIVE:                                             following that of its publication in the Official Journal of the
                                                                        European Communities.
                              Article 1
                                                                                                    Article 4
Annexes I and II, to Directive 1999/29/EC are amended in
accordance with the Annex to this Directive.                            This Directive is addressed to the Member States.
(1) OJ L 270, 14.12.1970, p. 1.
 ---pagebreak--- 27.11.2001           EN                            Official Journal of the European Communities                                                    C 332 E/245
                                                                           ANNEX
           Annexes I and II to Directive 1999/29/EC are amended as follows:
           1. In Annex I, under point B. Products, point 21 is replaced by the following:
                                                                                                             Maximum content relative to a
                           Substances products                           Feedingstuffs                   feedingstuff with a moisture content
                                                                                                                         of 12 %
              21. Dioxin (sum of polychlorinated             All feed materials of plant origin          0,75 ng WHO-PCDD/F-TEQ/
                    dibenzo-para-dioxins        (PCDDs)      including vegetable oils and                kg (5) (6)
                    and      polychlorinated      diben-     by-products
                    zofurans (PCDFs) expressed in
                    World       Health      Organisation
                    (WHO) toxic equivalents, using           Minerals                                    1,0 ng WHO-PCDD/F-TEQ/
                    the WHO TEFs (toxic equiv-                                                          kg (5) (6)
                    alency factors, 1997)) PCDD/F
                                                             Animal fat, including milk fat and          2,0 ng WHO-PCDD/F-TEQ/
                                                             egg fat                                     kg (5) (6)
                                                             Other land animal products                  0,75 ng WHO-PCDD/F-TEQ/
                                                             including milk and milk products            kg (5) (6)
                                                             and eggs and egg products.
                                                             Fish oil                                    6 ng WHO-PCDD/F-TEQ/
                                                                                                         kg (5) (6)
                                                             Fish, other aquatic animals, their          1,25 ng WHO-PCDD/F-TEQ/
                                                             products and by-products with the           kg (5) (6)
                                                             exception of fish oil
                                                             Compound feedingstuffs, with the            0,75 ng WHO-PCDD/F-TEQ/
                                                             exception of feedingstuffs for fur          kg (5) (6)
                                                             animals and feedingstuff for fish
                                                             Feedingstuffs for fish                      2,25 ng WHO-PCDD/F-TEQ/
                                                                                                         kg (5) (6)
              (5) Upperbound concentrations; upperbound concentrations are calculated assuming that all values of the different congeners less
                  than the limit of determination are equal to the limit of determination.
              (6) These maximum limits shall be reviewed for the first time before 31 December 2004 in the light of new data on the presence of
                  dioxins and dioxin-like PCBs, in particular with a view to the inclusion of dioxin-like PCBs in the levels to be set and will be
                  further reviewed before 31 December 2006 with the aim of significantly reducing of the maximum levels.
              (7) Fresh fish directly delivered and used without intermediate processing for the production of feedingstuffs for fur animals is
                  exempted from the maximum limit. The products, processed animal proteins produced from these fur animals cannot enter the
                  food chain and the feeding thereof is prohibited to farmed animals which are kept, fattened or bred for the production of food.
 ---pagebreak--- C 332 E/246           EN                            Official Journal of the European Communities                                                        27.11.2001
            2. In Annex II, point 4 of Part A is replaced by the following:
                                                                                                                Maximum content relative to a
                            Substances products                            Feedingstuffs                    feedingstuff with a moisture content
                                                                                                                            of 12 %
               4. Dioxin (sum of polychlorinated              All feed materials of plant origin            0,75 ng WHO-PCDD/F-TEQ/
                   dibenzo-para-dioxins (PCDDs) and           including vegetable oils and                  kg (2) (3)
                   polychlorinated         dibenzofurans      by-products
                   (PCDFs) expressed in World
                   Health Organisation (WHO) toxic
                   equivalents, using the WHO                 Minerals                                      1,0 ng WHO-PCDD/F-TEQ/
                   TEFs (toxic equivalency factors,                                                        kg (2) (3)
                   1997)) PCDD/F
                                                              Animal fat, including milk fat and            2,0 ng WHO-PCDD/F-TEQ/
                                                              egg fat.                                      kg (2) (3)
                                                              Other land animal products                    0,75 ng WHO-PCDD/F-TEQ/
                                                              including milk and milk products              kg (2) (3)
                                                              and eggs and egg products
                                                              Fish oil                                      6 ng WHO-PCDD/F-TEQ/
                                                                                                            kg (2) (3)
                                                              Fish, other aquatic animals, their            1,25 ng WHO-PCDD/F-TEQ/
                                                              products and by-products with the             kg (2) (3)
                                                              exception of fish oil
                                                              Compound feedingstuffs, with the              0,75 ng WHO-PCDD/F-TEQ/
                                                              exception of feedingstuffs for fur            kg (2) (3)
                                                              animals and feedingstuffs for fish
                                                              Feedingstuffs for fish                        2,25 ng WHO-PCDD/F-TEQ/
                                                                                                            kg (2) (3)
               (2) Upperbound concentrations; upperbound concentrations are calculated assuming that all values of the different congeners less
                   than the limit of determination are equal to the limit of determination.
               (3) These maximum levels shall be reviewed for the first time by 31 December 2004 at the latest in the light of new data on the
                   presence of dioxins and dioxin-like PCBs, in particular with a view to the inclusion of dioxin-like PCBs in the levels to be set and
                   will be further reviewed by 31 December 2006 at the latest with the aim of significantly reducing the maximum levels.
               (4) Fresh fish directly delivered and used without intermediate processing for the production of feedingstuffs for fur animals is
                   exempted from the maximum limit. The products, processed animal proteins produced from these fur animals cannot enter the
                   food chain and the feeding thereof is prohibited to farmed animals which are kept, fattened or bred for the production of food.