Avis juridique important

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31976L0399

Council Directive 76/399/EEC of 6 April 1976 making a fifth amendment to the Council Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the colouring matters authorized for use in foodstuffs intended for human consumption

Official Journal L 108 , 26/04/1976 P. 0019 - 0020 Finnish special edition: Chapter 13 Volume 4 P. 0229  Greek special edition: Chapter 03 Volume 15 P. 0044  Swedish special edition: Chapter 13 Volume 4 P. 0229  Spanish special edition: Chapter 13 Volume 5 P. 0003  Portuguese special edition Chapter 13 Volume 5 P. 0003

COUNCIL DIRECTIVE  of 6 April 1976  making a fifth amendment to the Council Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the colouring matters authorized for use in foodstuffs intended for human consumption  (76/399/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas the Council Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the colouring matters authorized for use in foodstuffs intended for human consumption (3), as last amended by Directive 70/358/EEC (4), lays down a common list of colouring matters;  Whereas since the adoption of that Directive there have been significant developments in methods for the toxicological investigation of food additives and in particular in the evaluation and interpretation of biological and chemical information;  Whereas, in the light of present-day requirements regarding the safety in use of colouring matters, certain colouring matters should no longer be permitted for use in foodstuffs;  Whereas the prohibition so required should be given effect under conditions which ensure the protection of public health, while avoiding as far as possible all disruption of a technological and economic nature,  HAS ADOPTED THIS DIRECTIVE:    Article 1 1. Annexes I and III to the Directive of 23 October 1962 are amended as follows:  The following colouring matters are deleted as from 1 January 1977:   >PIC FILE= "T9000943">  E 103 Chrysoine S,  E 105 Fast yellow AB,  E 111 Orange GGN,  E 121 Orchil, orcein,  E 125 Scarlet GN,  E 126 Ponceau 6 R,  E 130 Anthraquinone blue (solanthrene blue RS),  E 152 Black 7984,  E 181 Burnt umber.  2. The marketing of foodstuffs containing one or more of the colouring matters listed in paragraph 1 shall be prohibited as from 1 January 1978.  (1)OJ No L 79, 5.4.1976, p. 46. (2)OJ No C 50, 4.3.1976, p. 8. (3)OJ No 115, 11.11.1962, p. 2645/62. (4)OJ No L 157, 18.7.1970, p. 36.    Article 2 Member States which are authorized to prohibit, until 31 December 1975, the use in foodstuffs of one or more of the colouring matters listed in Article 1 (1) may maintain this prohibition beyond that date.   Article 3 Member States shall take all measures necessary to comply with this Directive on the dates fixed in Article 1 and shall forthwith inform the Commission thereof.   Article 4 This Directive is addressed to the Member States.     Done at Luxembourg, 6 April 1976.  For the Council  The President  J. HAMILIUS


Avis juridique important

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31990L0366

Council Directive 90/366/EEC of 28 June 1990 on the right of residence for students

Official Journal L 180 , 13/07/1990 P. 0030 - 0031

*****COUNCIL  DIRECTIVE  of 28 June 1990  on the right of residence for students  (90/366/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 235 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Article 3 (c) of the Treaty provides that the activities of the Community shall include, as provided in the Treaty, the abolition, as between Member States, of obstacles to freedom of movement for persons;  Whereas Article 8a of the Treaty provides that the internal market must be established by 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured in accordance with the provisions of the Treaty;  Whereas, as the Court of Justice has ruled, Articles 128 and 7 of the Treaty prohibit any discrimination between nationals of the Member States as regards access to vocational training in the Community;  Whereas the right of residence for students forms part of a set of related measures designed to promote vocational training;  Whereas beneficiaries of the right of residence must not become an unreasonable burden on the public finances of the host Member State;  Whereas, in the present state of Community law, assistance granted to students, as established by the case law of the Court of Justice, does not fall within the scope of the Treaty within the meaning of Article 7 thereof;  Whereas it is necessary for the Member States to adopt administrative measures to facilitate residence without discrimination;  Whereas the right of residence can only be genuinely exercised if it is granted to the spouse and their dependent children;  Whereas the beneficiaries of this Directive should be covered by administrative arrangements similar to those laid down in particular in Directive 68/360/EEC (4) and Directive 64/221/EEC (5);  Whereas this Directive does not apply to students who enjoy the right of residence by virtue of the fact that they are or have been effectively engaged in economic activities or are members of the family of a migrant worker;  Whereas the Treaty does not provide, for the action concerned, powers other than those of Article 235,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Member States shall, in order to facilitate access to vocational training, grant the right of residence to any student who is a national of a Member State and who does not enjoy this right under other provisions of Community law, and to the student's spouse and their dependent children, where the student assures the relevant national authority, by means of a declaration or by such alternative means as the student may choose that are at least equivalent, that he has sufficient resources to avoid becoming a burden on the social assistance system of the host Member State during their period of residence, provided that the student is enrolled in a recognized educational establishment for the principal purpose of following a vocational training course there and that they are covered by stickness insurance in respect of all risks in the host Member State.  Article 2  1. The right of residence shall be restricted to the duration of the course of studies in question.  The right of residence shall be evidenced by means of the issue of a document known as a 'Residence permit for a national of a Member State of the EEC', the validity of which may be limited to the duration of the course of studies or to one year where the course lasts longer; in the latter event it shall be renewable annually. Where a member of the family does not hold the nationality of a Member State, he or she shall be issued with a residence document of the same validity as that issued to the national on whom he or she depends.  For the purpose of issuing the residence permit or document, the Member State may require only that the applicant present a valid identity card or passport and provide proof that he or she meets the conditions laid down in Article 1.  2. Articles 2, 3 and 9 of Directive 68/360/EEC shall apply mutatis mutandis to the beneficiaries of this Directive.  The spouse and the dependent children of a national of a Member State entitled to the right of residence within the territory of a Member State shall be entitled to take up any employed or self-employed activity anywhere within the territory of that Member State, even if they are not nationals of a Member State.  Member States shall not derogate from the provisions of this Directive save on grounds of public policy, public security or public health: in that event, Articles 2 to 9 of Directive 64/221/EEC shall apply.  Article 3  This Directive shall not establish any entitlement to the payment of maintenance grants by the host Member State on the part of students benefiting from the right of residence.  Article 4  The right of residence shall remain for as long as beneficiaries of that right fulfil the conditions laid down in Article 1.  Article 5  The Commission shall, not more than three years after the date of implementation of this Directive, and at three-yearly intervals thereafter, draw up a report on the application of this Directive and submit it to the European Parliament and the Council.  The Commission shall pay particular attention to any difficulties to which the implementation of Article 1 might give rise in the Member States; it shall, if appropriate, submit proposals to the Council with the aim of remedying such difficulties.  Article 6  Member States shall bring into force the law, regulations and administrative provisions necessary to comply with this Directive not later than 30 June 1992. They shall forthwith inform the Commission thereof.  Article 7  This Directive is addressed to the Member States.  Done at Luxembourg, 28 June 1990.  For the Council  The President  M. GEOGHEGAN-QUINN  (1) OJ No C 191, 28. 7. 1989, p. 2;  and OJ No C 26, 3. 2. 1990, p. 15.  (2) Opinion delivered on 13 June 1990 (not yet published in the Official Journal).  (3) OJ No C 329, 30. 12. 1989, p. 25.  (4) OJ No L 257, 19. 10. 1968, p. 13.  (5) OJ No 56, 4. 4. 1964, p. 850/64.


title: Commission Directive 2006/13/EC of  3 February 2006  amending Annexes I and II to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed as regards dioxins and dioxin-like PCBs   (Text with EEA relevance)

text:
               4.2.2006

               EN

               Official Journal of the European Union

               L 32/44

      COMMISSION DIRECTIVE 2006/13/EC
   of 3 February 2006
   amending Annexes I and II to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed as regards dioxins and dioxin-like PCBs
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (1), and in particular Article 8(1) thereof,
   Whereas:

               (1)

               Directive 2002/32/EC provides that the putting into circulation and the use of products intended for animal feed that contain levels of undesirable substances exceeding the maximum levels laid down in Annex I thereto is prohibited.

               (2)

               The term ‘dioxins’ as referred to in this Directive covers a group of 75 polychlorinated dibenzo-p-dioxin congeners (PCDD) and 135 polychlorinated dibenzofuran (PCDF) congeners, of which 17 are of toxicological concern. 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 similar toxicological properties to dioxins and are therefore often termed ‘dioxin-like PCBs’. The other PCBs do not exhibit dioxin-like toxicity but they have a different toxicological profile.

               (3)

               Each congener of dioxins or dioxin-like PCBs exhibits a different level of toxicity. In order to be able to sum up 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 individual dioxin congeners and to the 12 dioxin-like PCB congeners are expressed in terms of a quantifiable unit, namely the ‘TCDD toxic equivalent concentration’ (TEQ).

               (4)

               On 30 May 2001 the Scientific Committee for Food (SCF) adopted an opinion on the Risk Assessment of Dioxins and Dioxin-like PCBs in Food, updating its opinion of 22 November 2000 on this subject on the basis of new scientific information that had become available since the latter’s adoption (2). The SCF fixed a tolerable weekly intake (TWI) of 14 pg WHO-TEQ/kg body weight for dioxins and dioxin-like PCBs. Exposure estimates indicate that a considerable proportion of the Community population have a dietary intake in excess of the TWI. Certain population groups in some countries could be at higher risk owing to particular dietary habits.

               (5)

               More than 90 % of human dioxin and dioxin-like PCB exposure derives from foodstuffs. Foodstuffs of animal origin normally contribute approximately 80 % of overall exposure. The dioxin and dioxin-like PCB burden in animals stems mainly from feedingstuffs. Therefore feedingstuffs, and in some cases soil, are of concern as potential sources of dioxins and dioxin-like PCBs.

               (6)

               The Scientific Committee for Animal Nutrition (SCAN) has been asked to advise on the sources of contamination of feedingstuffs with dioxins and PCBs, including dioxin-like PCBs, the exposure of food-producing 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 the most heavily contaminated feed materials. Animal fat was identified as the next most seriously contaminated material. All other feed materials of animal and plant origin had relatively low levels of dioxin contamination. Roughages presented a wide range of dioxin contamination depending on location, degree of contamination with soil and exposure to sources of aerial pollution. The SCAN recommended, inter alia, that emphasis should be placed on reducing the impact of the most contaminated feed materials on overall diet contamination.

               (7)

               Although, from a toxicological point of view, the maximum level should apply to dioxins and dioxin-like PCBs, maximum levels were set for dioxins only and not for dioxin-like PCBs, given the very limited data available at that time on the prevalence of dioxin-like PCBs. However, in the meantime more data on the presence of dioxin-like PCBs have become available.

               (8)

               According to Directive 2002/32/EC, the Commission should review the provisions as regards dioxins by the end of 2004 for the first time, 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.

               (9)

               All operators in the food and feed chain must continue to make all possible efforts to do all that is necessary to limit the presence of dioxins and PCBs present in feed and food. Directive 2002/32/EC accordingly provides that the maximum levels applicable should be further reviewed by 31 December 2006 at the latest with the aim of significantly reducing the maximum levels. Given the time necessary to obtain sufficient monitoring data to determine such significantly lower levels, that time-limit should be extended.

               (10)

               It is proposed to set maximum levels for the sum of dioxins and dioxin-like PCBs expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs as this is the most appropriate approach from a toxicological point of view. In order to ensure a smooth switchover, for a transitional period the existing levels for dioxins should continue to apply, in addition to the newly set levels for the sum of dioxins and dioxin-like PCBs. The separate maximum level for dioxins (PCDD/F) remains applicable for a temporary period. The products intended for animal feed mentioned in point 27a have to comply during that period with the maximum levels for dioxins and with the maximum levels for the sum of dioxins and dioxin-like PCBs. Consideration will be given by 31 December 2008 to dispensing with the separate maximum level for dioxins.

               (11)

               It is of major importance that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised enforcement approach throughout the Community. Commission Directive 2002/70/EC of 26 July 2002 establishing requirements for the determination of levels of dioxins and dioxin-like PCBs in feedingstuffs (3) provides that a product intended for animal feeding shall be considered as non-compliant with the established maximum level if the analytical result confirmed by duplicate analysis and calculated as the mean of at least two separate determinations exceeds the maximum level beyond reasonable doubt taking into account the measurement uncertainty. There are different possibilities to estimate the expanded uncertainty (4).

               (12)

               The scope of Directive 2002/32/EC covers the possibility of establishing maximum levels of undesirable substances in feed additives. Since high levels of dioxins have been found in trace elements, a maximum level should be established for dioxins and the sum of dioxins and dioxin-like PCBs for all additives belonging to the functional group of compounds of trace elements and the maximum levels should be extended to all additives belonging to the functional group of binders and anti-caking agents and to premixtures.

               (13)

               In order to encourage a proactive approach to reducing the dioxins and dioxin-like PCBs present in food and feed, action levels were set by Commission Recommendation 2002/201/EC of 4 March 2002 on the reduction of the presence of dioxins, furans and PCBs in feedingstuffs and foodstuffs (5). Those action levels are a tool for competent authorities and operators to highlight those cases where it is appropriate to identify a source of contamination and to take measures to reduce or eliminate it. Since the sources of dioxins and dioxin-like PCBs are different, separate action levels should be determined for dioxins on the one hand and for dioxin-like PCBs on the other hand.

               (14)

               Directive 2002/32/EC provides for the possibility of setting action levels. The action levels should therefore be transferred from Recommendation 2002/201/EC to Annex II to Directive 2002/32/EC.

               (15)

               The reduction of human exposure to dioxins and dioxin-like PCBs through food consumption is important and necessary to ensure consumer protection. As food contamination is directly related to feed contamination, an integrated approach must be adopted to reduce dioxin and dioxin-like PCB incidence throughout the food chain, i.e. from products intended for animal feed through food-producing animals to humans. A proactive approach is followed to actively reduce the dioxins and dioxin-like PCBs in feed and food and consequently the maximum levels applicable should be reviewed within a defined period of time with the objective to set lower levels. Therefore consideration will be given by 31 December 2008 at the latest to significantly reducing the maximum levels for the sum of dioxins and dioxin-like PCBs.

               (16)

               Operators need to make efforts to step up their decontamination capacity to remove effectively dioxins and dioxin-like PCBs from fish oil. Further efforts have to done by the operators to investigate the different possibilities to remove dioxins and dioxin-like PCBs from fish meal and fish protein-hydrolysates. Once the decontamination technology is also available for fish meal and fish protein hydrolysates, operators will have to do efforts to provide for sufficient decontamination capacity. The significant lower maximum level for the sum of dioxins and dioxin-like PCBs, to which consideration shall be given by 31 December 2008, shall be for fish oil, fish meal and fish protein hydrolysates based on the technical possibilities of the most effective, economically viable, decontamination procedure. As regards fish feed, this significant lower level shall be determined based on the technical possibilities of the most effective, economically viable, decontamination procedure for fish oil and fish meal.

               (17)

               The extraction procedure used for the analysis of dioxins and dioxin-like PCBs has a large influence on the analytical result in particular on products intended for animal feed of mineral origin and it is therefore appropriate to determine before the date of application the extraction procedure to be used for the analysis of dioxins and dioxin-like PCBs.

               (18)

               Directive 2002/32/EC should therefore be amended accordingly.

               (19)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes I and II to Directive 2002/32/EC are amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 4 November 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they 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 made.
   2.   Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 3 February 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 140, 30.5.2002, p. 10. Directive as last amended by Directive 2005/87/EC (OJ L 318, 6.12.2005, p. 19).

      (2)  Opinion of the Scientific Committee on Food on the Risk Assessment of Dioxins and Dioxin-like PCBs in Food adopted on 30 May 2001 — Update based on new scientific information available since the adoption of the SCF opinion of 22 November 2000 (http://europa.eu.int/comm/food/fs/sc/scf/out90_en.pdf).

      (3)  OJ L 209, 6.8.2002, p. 15. Directive as amended by Directive 2005/7/EC (OJ L 27, 29.1.2005, p. 41).

      (4)  Information on different ways for the estimation of the expanded uncertainty and on the value of the measurement uncertainty can be found in the report ‘Report on the relationship between analytical results, measurement uncertainty, recovery factors and the provisions of EU food and feed legislation’ — http://europa.eu.int/comm/food/food/chemicalsafety/contaminants/report-sampling_analysis_2004_en.pdf

      (5)  OJ L 67, 9.3.2002, p. 69.

      ANNEX

                  (a)

                  Point 27 in Annex I to Directive 2002/32/EC is replaced by the following:

                              Undesirable substances

                              Products intended for animal feed

                              Maximum content relative to a feedingstuff with a moisture content of 12 %

                              (1)

                              (2)

                              (3)

                                          ‘27a.

                                          Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 1997 (1)

                                          (a)

                                          Feed materials of plant origin with the exception of vegetable oils and their by-products

                              0,75 ng WHO-PCDD/F-TEQ/kg (2)
                                  (3)

                                          (b)

                                          Vegetable oils and their by-products

                              0,75 ng WHO-PCDD/F-TEQ/kg (2)
                                  (3)

                                          (c)

                                          Feed materials of mineral origin

                              1,0 ng WHO-PCDD/F-TEQ/kg (2)
                                  (3)

                                          (d)

                                          Animal fat, including milk fat and egg fat

                              2,0 ng WHO-PCDD/F-TEQ/kg (2)
                                  (3)

                                          (e)

                                          Other land animal products including milk and milk products and eggs and egg products

                              0,75 ng WHO-PCDD/F-TEQ/kg (2)
                                  (3)

                                          (f)

                                          Fish oil

                              6,0 ng WHO-PCDD/F-TEQ/kg (2)
                                  (3)

                                          (g)

                                          Fish, other aquatic animals, their products and by-products with the exception of fish oil and fish protein hydrolysates containing more than 20 % fat (4)

                              1,25 ng WHO-PCDD/F-TEQ/kg (2)
                                  (3)

                                          (h)

                                          Fish protein hydrolysates containing more than 20 % fat

                              2,25 ng WHO-PCDD/F-TEQ/kg (2)
                                  (3)

                                          (i)

                                          The additives kaolinitic clay, calcium sulphate dihydrate, vermiculite, natrolite-phonolite, synthetic calcium aluminates and clinoptilolite of sedimentary origin belonging to the functional groups of binders and anti-caking agents

                              0,75 ng WHO-PCDD/F-TEQ/kg (2)
                                  (3)

                                          (j)

                                          Additives belonging to the functional group of compounds of trace elements

                              1,0 ng WHO-PCDD/F-TEQ/kg (2)
                                  (3)

                                          (k)

                                          Premixtures

                              1,0 ng WHO-PCDD/F-TEQ/kg (2)
                                  (3)

                                          (l)

                                          Compound feedingstuffs, with the exception of feed for fur animals, pet foods and feed for fish

                              0,75 ng WHO-PCDD/F-TEQ/kg (2)
                                  (3)

                                          (m)

                                          Feed for fish.
                                          Pet foods

                              2,25 ng WHO-PCDD/F-TEQ/kg (2)
                                  (3)

                                          27b.

                                          Sum of dioxins and dioxin-like PCBs (sum of polychlorinated dibenzo-para-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 1997 (1)

                                          (a)

                                          Feed materials of plant origin with the exception of vegetable oils and their by-products

                              1,25 ng WHO-PCDD/F-PCB-TEQ/kg (2)

                                          (b)

                                          Vegetable oils and their by-products

                              1,5 ng WHO-PCDD/F-PCB-TEQ/kg (2)

                                          (c)

                                          Feed materials of mineral origin

                              1,5 ng WHO-PCDD/F-PCB-TEQ/kg (2)

                                          (d)

                                          Animal fat, including milk fat and egg fat

                              3,0 ng WHO-PCDD/F-PCB-TEQ/kg (2)

                                          (e)

                                          Other land animal products including milk and milk products and eggs and egg products

                              1,25 ng WHO-PCDD/F-PCB-TEQ/kg (2)

                                          (f)

                                          Fish oil

                              24,0 ng WHO-PCDD/F-PCB-TEQ/kg (2)

                                          (g)

                                          Fish, other aquatic animals, their products and by-products with the exception of fish oil and fish protein hydrolysates containing more than 20 % fat (4)

                              4,5 ng WHO-PCDD/F-PCB-TEQ/kg (2)

                                          (h)

                                          Fish protein hydrolysates containing more than 20 % fat

                              11,0 ng WHO-PCDD/F-PCB-TEQ/kg (2)

                                          (i)

                                          Additives belonging to the functional groups of binders and anti-caking agents

                              1,5 ng WHO-PCDD/F-PCB-TEQ/kg (2)

                                          (j)

                                          Additives belonging to the functional group of compounds of trace elements

                              1,5 ng WHO-PCDD/F-PCB-TEQ/kg (2)

                                          (k)

                                          Premixtures

                              1,5 ng WHO-PCDD/F-PCB-TEQ/kg (2)

                                          (l)

                                          Compound feedingstuffs, with the exception of feed for fur animals, pet foods and feed for fish

                              1,5 ng WHO-PCDD/F-PCB-TEQ/kg (2)

                                          (m)

                                          Feed for fish.
                                          Pet foods

                              7,0 ng WHO-PCDD/F-PCB-TEQ/kg (2)

                  (b)

                  Annex II to Directive 2002/32/EC is replaced by the following:

                              ‘Undesirable substances

                              Products intended for animal feed

                              Action threshold relative to a feedingstuff with a moisture content of 12 %

                              Comments and additional information (e.g. nature of investigations to be performed)

                              (1)

                              (2)

                              (3)

                              (4)

                                          1.

                                          Dioxins (sum of polychlorinated dibenzo-para-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 1997 (5)

                                          (a)

                                          Feed materials of plant origin with the exception of vegetable oils and their by-products

                              0,5 ng WHO-PCDD/F-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (b)

                                          Vegetable oils and their by-products

                              0,5 ng WHO-PCDD/F-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (c)

                                          Feed materials of mineral origin

                              0,5 ng WHO-PCDD/F-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (d)

                                          Animal fat, including milk fat and egg fat

                              1,0 ng WHO-PCDD/F-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (e)

                                          Other land animal products including milk and milk products and eggs and egg products

                              0,5 ng WHO-PCDD/F-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (f)

                                          Fish oil

                              5,0 ng WHO-PCDD/F-TEQ/kg (6)
                                  (7)

                              In many cases it might not be necessary to perform an investigation into the source of contamination as the background level in some areas is close to or above the action level. However, in cases where the action level is exceeded all information, such as sampling period, geographical origin, fish species etc., should be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition.

                                          (g)

                                          Fish, other aquatic animals, their products and by-products with the exception of fish oil and fish protein hydrolysates containing more than 20 % fat

                              1,0 ng WHO-PCDD/F-TEQ/kg (6)
                                  (7)

                              In many cases it might not be necessary to perform an investigation into the source of contamination as the background level in some areas is close to or above the action level. However, in cases where the action level is exceeded, all information, such as sampling period, geographical origin, fish species etc., must be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition.

                                          (h)

                                          Fish protein hydrolysates containing more than 20 % fat

                              1,75 ng WHO-PCDD/F-TEQ/kg (6)
                                  (7)

                              In many cases it might not be necessary to perform an investigation into the source of contamination as the background level in some areas is close to or above the action level. However, in cases where the action level is exceeded, all information, such as sampling period, geographical origin, fish species etc., must be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition.

                                          (i)

                                          Additives belonging to the functional groups of binders and anti-caking agents

                              0,5 ng WHO-PCDD/F-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (j)

                                          Additives belonging to the functional group of compounds of trace elements

                              0,5 ng WHO-PCDD/F-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (k)

                                          Premixtures

                              0,5 ng WHO-PCDD/F-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (l)

                                          Compound feedingstuffs, with the exception of feedingstuffs for fur animals, pet foods and feedingstuffs for fish

                              0,5 ng WHO-PCDD/F-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (m)

                                          Feedingstuffs for fish.
                                          Pet foods

                              1,75 ng WHO-PCDD/F-TEQ/kg (6)
                                  (7)

                              In many cases it might not be necessary to perform an investigation into the source of contamination as the background level in some areas is close to or above the action level. However, in cases where the action level is exceeded, all information, such as sampling period, geographical origin, fish species etc., must be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition.

                                          2.

                                          Dioxin like PCBs (sum of polychlorinated biphenyls (PCBs) expressed in World Health Organisation (WHO) toxic equivalents, using the WHO-TEFs (toxic equivalency factors, 1997 (5)

                                          (a)

                                          Feed materials of plant origin with the exception of vegetable oils and their by-products

                              0,35 ng WHO-PCB-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (b)

                                          Vegetable oils and their by-products

                              0,5 ng WHO-PCB-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (c)

                                          Feed materials of mineral origin

                              0,35 ng WHO-PCB-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (d)

                                          Animal fat, including milk fat and egg fat

                              0,75 ng WHO-PCB-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (e)

                                          Other land animal products including milk and milk products and eggs and egg products

                              0,35 ng WHO-PCB-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (f)

                                          Fish oil

                              14,0 ng WHO-PCB-TEQ/kg (6)
                                  (7)

                              In many cases it might not be necessary to perform an investigation into the source of contamination as the background level in some areas is close to or above the action level. However, in cases where the action level is exceeded, all information, such as sampling period, geographical origin, fish species etc., must be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition.

                                          (g)

                                          Fish, other aquatic animals, their products and by-products with the exception of fish oil and fish protein hydrolysates containing more than 20 % fat

                              2,5 ng WHO-PCB-TEQ/kg (6)
                                  (7)

                              In many cases it might not be necessary to perform an investigation into the source of contamination as the background level in some areas is close to or above the action level. However, in cases where the action level is exceeded, all information, such as sampling period, geographical origin, fish species etc., must be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition.

                                          (h)

                                          Fish protein hydrolysates containing more than 20 % fat

                              7,0 ng WHO-PCB-TEQ/kg (6)
                                  (7)

                              In many cases it might not be necessary to perform an investigation into the source of contamination as the background level in some areas is close to or above the action level. However, in cases where the action level is exceeded, all information, such as sampling period, geographical origin, fish species etc., must be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition.

                                          (i)

                                          Additives belonging to the functional groups of binders and anti-caking agents

                              0,5 ng WHO-PCB-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (j)

                                          Additives belonging to the functional group of compounds of trace elements

                              0,35 ng WHO-PCB-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (k)

                                          Premixtures

                              0,35 ng WHO-PCB-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (l)

                                          Compound feedingstuffs, with the exception of feedingstuffs for fur animals, pet foods and feedingstuffs for fish

                              0,5 ng WHO-PCB-TEQ/kg (6)
                                  (7)

                              Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination.

                                          (m)

                                          Feedingstuffs for fish.
                                          Pet foods

                              3,5 ng WHO-PCB-TEQ/kg (6)
                                  (7)

                              In many cases it might not be necessary to perform an investigation into the source of contamination as the background level in some areas is close to or above the action level. However, in cases where the action level is exceeded, all information, such as sampling period, geographical origin, fish species etc., must be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition.

         (1)  WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation meeting in Stockholm, Sweden, 15-18 June 1997 (Van den Berg et al., (1998) Toxic Equivalency Factors (TEFs) for PCBs, PCDDs, and PCDFs for Humans and for Wildlife. Environmental Health Perspectives, 106(12), 775).

         (2)  Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification.

         (3)  The separate maximum level for dioxins (PCDD/F) remains applicable for a temporary period. The products intended for animal feed mentioned in point 27a have to comply both with the maximum levels for dioxins and with the maximum levels for the sum of dioxins and dioxin-like PCBs during that temporary period.

         (4)  Fresh fish directly delivered and used without intermediate processing for the production of feed for fur animals is not subject to the maximum levels, while maximum levels of 4,0 ng WHO-PCDD/F-TEQ/kg product and 8,0 ng WHO-PCDD/F-PCB-TEQ/kg product are applicable to fresh fish used for the direct feeding of pet animals, zoo and circus animals. The products, processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food.’

         (5)  WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation meeting in Stockholm, Sweden, 15-18 June 1997 (Van den Berg et al., (1998) Toxic Equivalency Factors (TEFs) for PCBs, PCDDs, PCDFs for Humans and for Wildlife. Environmental Health Perspectives, 106(12), 775).

         (6)  Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification.

         (7)  The Commission will review these action levels by 31 December 2008 at the latest at the same time as it reviews the maximum levels for the sum of dioxins and dioxin-like PCBs.’


title: Commission Directive 2009/36/EC of 16 April 2009 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress (Text with EEA relevance )

text:
               17.4.2009

               EN

               Official Journal of the European Union

               L 98/31

      COMMISSION DIRECTIVE 2009/36/EC
   of 16 April 2009
   amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 8(2) thereof,
   After consulting the Scientific Committee on Consumer Products,
   Whereas:

               (1)

               Following the publication of a scientific study in 2001, entitled ‘Use of permanent hair dyes and bladder cancer risk’, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, currently the Scientific Committee on Consumer Products (hereinafter SCCP) (2), concluded that the potential risks were of concern. It recommended that the Commission take further steps to control the use of hair dye substances.

               (2)

               The SCCP further recommended an overall safety assessment strategy for hair dye substances including the requirements for testing substances used in hair dye products for their potential genotoxicity/mutagenicity.

               (3)

               Following the opinions of the SCCP, the Commission, together with Member States and stakeholders, agreed on an overall strategy to regulate substances used in hair dye products, according to which the industry was required to submit files containing the scientific data on hair dye substances to be evaluated by the SCCP.

               (4)

               Substances for which updated safety files were submitted are currently being evaluated by the SCCP. For 17 hair dye substances final opinions have already been given by the SCCP. Therefore, definitive regulation of these hair dye substances, on the basis of such evaluations, can take place.

               (5)

               Directive 76/768/EEC should therefore be amended accordingly.

               (6)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex III to Directive 76/768/EEC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 15 November 2009 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
   They shall apply the provisions set out in the Annex to this Directive from 15 May 2010.
   When Member States adopt those provisions, they 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 made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 16 April 2009.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 262, 27.9.1976, p. 169.

      (2)  The name of the committee was changed by Commission Decision 2004/210 (OJ L 66, 4.3.2004, p. 45).

      ANNEX
      Directive 76/768/EEC is amended as follows:

                  1.

                  In Part 1 of Annex III the following reference numbers 189 - 205 are added:

                              Reference number

                              Substance

                              Restrictions

                              Conditions of use and warnings which must be printed on the label

                              Field of application and/or use

                              Maximum authorized concentration in the finished cosmetic product

                              Other limitations and requirements

                              a

                              b

                              c

                              d

                              e

                              f

                              ‘189

                              Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate and aluminium lake (1)

                              Acid Yellow 23
                              CAS 1934-21-0
                              EINECS 217-699-5
                              Acid Yellow 23 Aluminum lake
                              CAS 12225-21-7
                              EINECS 235-428-9
                              CI 19140

                              Hair dye substance in non-oxidative hair dye products

                              0,5 %

                              190

                              Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl-[(3-sulfophenyl)-methyl]-amino]-phenyl] [2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo, inner salt, disodium salt and its ammonium and aluminium salts (1)

                              Acid Blue 9
                              CAS 3844-45-9
                              EINECS 223-339-8
                              Acid Blue 9 Ammonium salt
                              CAS 2650-18-2
                              EINECS 220-168-0
                              Acid Blue 9 Aluminum lake
                              CAS 68921-42-6
                              EINECS 272-939-6
                              CI 42090

                              Hair dye substance in non-oxidative hair dye products

                              0,5 %

                              191

                              Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate (1)

                              Curry Red
                              CAS 25956-17-6
                              EINECS 247-368-0
                              CI 16035

                              Hair dye substance in non-oxidative hair dye products

                              0,4 %

                              192

                              Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4′,6,8-trisulphonate and aluminium lake (1)

                              Acid Red 18
                              CAS 2611-82-7
                              EINECS 220-036-2
                              Acid Red 18 Aluminum lake
                              CAS 12227-64-4
                              EINECS 235-438-3
                              CI 16255

                              Hair dye substance in non-oxidative hair dye products

                              0,5 %

                              193

                              Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium salt (1)

                              Acid Red 52
                              CAS 3520-42-1
                              EINECS 222-529-8
                              CI 45100

                                          (a)

                                          Hair dye substance in oxidative hair dye products

                                          (b)

                                          Hair dye substance in non-oxidative hair dye products

                                          (b)

                                          0,6 %

                                          (a)

                                          After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %.

                                          (a)

                                          The mixing ratio must be printed on the label.

                              194

                              Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (1)

                              Acid Red 33
                              CAS 3567-66-6
                              EINECS 222-656-9
                              CI 17200

                              Hair dye substance in non-oxidative hair dye products

                              0,5 %

                              195

                              Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate (1)

                              Acid Blue 62
                              CAS 4368-56-3
                              EINECS 224-460-9
                              CI 62045

                              Hair dye substance in non-oxidative hair dye products

                              0,5 %

                                          —

                                          Do not use with nitrosating systems

                                          —

                                          Maximum nitrosamine content: 50 μg/kg

                                          —

                                          Keep in nitrite-free containers

                              196

                              1-[(2′-Methoxyethyl)amino]-2-nitro-4-[di-(2′-hydroxyethyl)amino]benzene (1)

                              HC Blue No 11
                              CAS 23920-15-2
                              EINECS 459-980-7

                              Hair dye substance in non-oxidative hair dye products

                              2,0 %

                                          —

                                          Do not use with nitrosating systems

                                          —

                                          Maximum nitrosamine content: 50 μg/kg

                                          —

                                          Keep in nitrite-free containers

                              197

                              1,5-Di-(ß-hydroxyethylamino)-2-nitro-4-chlorobenzene (1)

                              HC Yellow No 10
                              CAS 109023-83-8
                              EINECS 416-940-3

                              Hair dye substance in non-oxidative hair dye products

                              0,1 %

                                          —

                                          Do not use with nitrosating systems

                                          —

                                          Maximum nitrosamine content: 50 μg/kg

                                          —

                                          Keep in nitrite-free containers

                              198

                              3-Methylamino-4-nitrophenoxyethanol (1)

                              3-Methylamino-4-nitrophenoxyethanol (INCI)
                              CAS 59820-63-2
                              EINECS 261-940-7

                              Hair dye substance in non-oxidative hair dye products

                              0,15 %

                                          —

                                          Do not use with nitrosating systems

                                          —

                                          Maximum nitrosamine content: 50 μg/kg

                                          —

                                          Keep in nitrite-free containers

                              199

                              2,2′-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol (1)

                              HC Blue No 2
                              CAS 33229-34-4
                              EINECS 251-410-3

                              Hair dye substance in non-oxidative hair dye products

                              2,8 %

                                          —

                                          Do not use with nitrosating systems

                                          —

                                          Maximum nitrosamine content: 50 μg/kg

                                          —

                                          Keep in nitrite-free containers

                              Can cause allergic reaction

                              200

                              1-Propanol, 3-[[4-[bis(2-hydroxyethyl)amino]-2-nitrophenyl]amino] (1)

                              HC Violet No 2
                              CAS 104226-19-9
                              EINECS 410-910-3

                              Hair dye substance in non-oxidative hair dye products

                              2,0 %

                                          —

                                          Do not use with nitrosating systems

                                          —

                                          Maximum nitrosamine content: 50 μg/kg

                                          —

                                          Keep in nitrite-free containers

                              Can cause allergic reaction

                              201

                              Phenol, 2-chloro-6-(ethylamino)-4-nitro- (1)

                              2-Chloro-6-ethylamino-4-nitrophenol
                              CAS 131657-78-8
                              EINECS 411-440-1

                              Hair dye substance in non-oxidative hair dye products

                              3,0 %

                                          —

                                          Do not use with nitrosating systems

                                          —

                                          Maximum nitrosamine content: 50 μg/kg

                                          —

                                          Keep in nitrite-free containers

                              Can cause allergic reaction

                              202

                              4,4′-[1,3-Propanediylbis(oxy)]bisbenzene-1,3-diamine and its tetrahydrochloride salt (1)

                              1,3-bis-(2,4-Diaminophenoxy)propane
                              CAS 81892-72-0
                              EINECS 279-845-4
                              1,3-bis-(2,4-Diaminophenoxy)propane HCl
                              CAS 74918-21-1
                              EINECS 278-022-7

                                          (a)

                                          Hair dye substance in oxidative hair dye products

                                          (b)

                                          Hair dye substance in non-oxidative hair dye products

                                          (b)

                                          1,2 % as free base (1,8 % as tetrahydrochloride salt)

                                          (a)

                                          After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,2 % calculated as free base (1,8 % as tetrahydrochloride salt).

                                          (a)

                                          The mixing ratio must be printed on the label.

                                    For (a) and (b):
                              Can cause allergic reaction

                              203

                              6-Methoxy-N2-methyl-2,3-pyridinediamine hydrochloride and dihydrochloride salt (1)

                              6-Methoxy-2-methylamino-3-aminopyridine HCl
                              CAS 90817-34-8 (HCl)
                              CAS 83732-72-3 (2HCl)
                              EINECS 280-622-9 (2HCl)

                                          (a)

                                          Hair dye substance in oxidative hair dye products

                                          (b)

                                          Hair dye substance in non-oxidative hair dye

                                          (b)

                                          0,68 % as free base (1,0 % as dihydrochloride)

                                          (a)

                                          After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,68 % calculated as free base (1,0 % as dihydrochloride).

                                    For a) and b):

                                          —

                                          Do not use with nitrosating systems

                                          —

                                          Maximum nitrosamine content: 50 μg/kg

                                          —

                                          Keep in nitrite-free containers

                                          (a)

                                          The mixing ratio must be printed on the label.

                                    For (a) and (b):
                              Can cause allergic reaction

                              204

                              2,3-Dihydro-1H-indole-5,6-diol and its hydrobromide salt (1)

                              Dihydroxyindoline
                              CAS 29539-03-5
                              Dihydroxyindoline HBr
                              CAS 138937-28-7
                              EINECS 421-170-6

                              Hair dye substance in non-oxidative hair dye products

                              2,0 %

                              Can cause allergic reaction

                              205

                              4-Hydroxypropylamino-3-nitrophenol (1)

                              4-Hydroxypropylamino-3-nitrophenol (INCI)
                              CAS 92952-81-3
                              EINECS 406-305-9

                                          (a)

                                          Hair dye substance in oxidative hair dye products

                                          (b)

                                          Hair dye substance in non-oxidative hair dye products

                                          (b)

                                          2,6 %

                                          (a)

                                          After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,6 % calculated as free base.

                                    For (a) and (b):

                                          —

                                          Do not use with nitrosating systems

                                          —

                                          Maximum nitrosamine content: 50 μg/kg

                                          —

                                          Keep in nitrite-free containers

                                          (a)

                                          The mixing ratio must be printed on the label.

                  2.

                  In columns ‘c’ and ‘d’ of entry 55 of Part 2 of Annex III section b is deleted.

                  3.

                  In Part 2 of Annex III reference numbers 7, 9, 14, 24, 28, 47, and 58 are deleted.

         (1)  The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are permitted for use.’