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31985L0321

Council Directive 85/321/EEC of 12 June 1985 amending Directive 80/215/EEC as regards certain measures relating to African swine fever

Official Journal L 168 , 28/06/1985 P. 0039 - 0040 Finnish special edition: Chapter 3 Volume 18 P. 0200  Spanish special edition: Chapter 03 Volume 35 P. 0172  Swedish special edition: Chapter 3 Volume 18 P. 0200  Portuguese special edition Chapter 03 Volume 35 P. 0172

*****COUNCIL  DIRECTIVE  of 12 June 1985  amending Directive 80/215/EEC as regards certain measures relating to African swine fever  (85/321/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 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 Directive 80/215/EEC (4), as last amended by Directive 81/476/EEC (5), lays down the health requirements to be fulfilled by meat products intended for intra-Community trade;  Whereas, even if it occurs only exceptionally in certain parts of the territory of the Community, African swine fever constitutes a risk of contamination to the pig herds of the Member States; whereas rules should therefore be established laying down protective measures to be applied in intra-Community trade in pigmeat products which have not undergone treatment to destroy the virus of the disease,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 80/215/EEC is hereby amended as follows:  1. The following subparagraph is added to Article 7 (1):  'However, where the disease in question is African swine fever, Article 7a shall apply.'  2. The following Article is inserted:  'Article 7a  1. A Member State in whose territory African swine fever has been recorded within the previous 12 months shall not export to the territory of other Member States pigmeat products other than those having undergone the treatment referred to in Article 4 (1) (a).  It may be decided, in accordance with the procedure laid down in Article 8, that the provisions of the first subparagraph shall not apply to one or more parts of the territory of the Member State concerned. This derogation shall not preclude recourse to Article 7 should one or more cases of African swine fever re-occur in the above part or parts of territory.  2. Where there is an outbreak of African swine fever in the territory of a Member State where the disease has not been recorded for at least 12 months, it may be decided, in accordance with the procedure laid down in Article 8, that the provisions of paragraph 1 shall apply exclusively to a part of territory concerned. Pending this decision, and without prejudice to Article 7, the Member State concerned shall ensure the immediate prohibition of export to the other Member States of pigmeat products from the part of territory in which the epizootic disease has been recorded. The criteria laid down in Article 7b (2) shall be taken into account in determining that part of the territory.  One or more cases of African swine fever on a part of a Member State's territory which is not geographically linked to the main part of that Member State's territory shall not prevent the application of the first subparagraph.  The conditions prerequisite to the application of the first subparagraph shall still be deemed to be fulfilled if the following conditions have been fulfilled:  (i) the outbreak or outbreaks recorded on the occurrence of African swine fever referred to in the first subparagraph was or were eradicated in the shortest possible period of time;  (ii) the new outbreak, which forms the subject of a fresh request for a decision, as provided for in the first subparagraph, is not connected epidemiologically with the outbreak or outbreaks referred to in (i).  3. Decisions to lift measures applied under paragraph 2 shall be taken in accordance with the procedure laid down in Article 8.'  3. The following Article is inserted:  'Article 7b  1. For the purposes of defining the parts of territory referred to in Article 7a (1), particular account shall be taken of:  - the methods used to control and eradicate African swine fever,  - the absence of the disease for at least 12 months, recorded by all the methods of detection, including serological surveys,  - the surface area of the parts of territory and their administrative and geographical boundaries,  - the protective measures taken to prevent the contamination or recontamination of pig herds,  - the measures taken to control the movement of pigs.  2. For the purposes of defining the parts of territory referred to in Article 7a (2), particular account shall be taken of:  - the methods used to combat the disease, in particular the elimination of pigs from holdings which are infected, contaminated or suspected of contamination,  - the surface area of the parts of territory and their administrative and geographical boundaries,  - the incidence of the disease and its tendency to spread,  - the measures taken to prevent the disease from spreading,  - the measures taken to restrict and control the movement of pigs both inside and outside the part of territory concerned;  and, in the case of non-application of prohibition measures to certain products:  - the treatment to which the products have been subjected,  - the manufacturing dates, and  - the measures taken to determine and guarantee the date of manufacture.'  Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1986.  They shall forthwith inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Luxembourg, 12 June 1985.  For the Council  The President  C. DEGAN  (1) OJ No C 272, 12. 10. 1984, p. 6.  (2) OJ No C 12, 14. 1. 1985, p. 127.  (3) OJ No C 44, 15. 2. 1985, p. 4.  (4) OJ No L 47, 21. 2. 1980, p. 4.  (5) OJ No L 186, 8. 7. 1981, p. 20.


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31991L0184

Thirteenth Commission Directive 91/184/EEC of 12 March 1991 adapting to technical progress Annexes II, III, IV, V, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products

Official Journal L 091 , 12/04/1991 P. 0059 - 0062 Finnish special edition: Chapter 13 Volume 20 P. 0067  Swedish special edition: Chapter 13 Volume 20 P. 0067

THIRTEENTH COMMISSION DIRECTIVE  of 12 March 1991  adapting to technical progress Annexes II, III, IV, V, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products  (91/184/EEC) THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic 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), as last amended by Directive 90/121/EEC (2), and in particular Article 8 (2) thereof,  Whereas, on the basis of the available information, certain provisionally permitted colouring agents, substances and preservatives may be definitively permitted, while others must be definitively prohibited or be permitted for a further specified  period;  Whereas, in order to protect public health, it is necessary to prohibit the use of lidocaine and thiomersal;  Whereas, on the basis of the latest scientific and technical research, the use of magnesium fluoride may be permitted subject to certain restrictions and obligatory inclusion on the label of health warnings;  Whereas, on the basis of the latest scientific and technical research, 7-ethyl bicyclo-oxazolidine may be used as a preservative up to 31 December 1992 and 3,3-(1.4-phenylene dimethylidyne) bis (7,7-dimethyl-2-oxo-bicyclo-(2,2,1) heptane-1-methane  sulphonic acid) and its salts may be used as an ultraviolet filter in cosmetic products subject to certain restrictions and conditions;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the removal of technical barriers to trade in the cosmetic products sector,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 76/768/EEC is hereby amended as follows:  1. Annex II  (a) No 221, 'in Annexes V and VI, Part 1' is replaced by 'in Annex VI, Part 1';  (b) the following numbers are added:   '395.  hydroxy-8-quinoline and its sulphate, except for the uses provided for in No 51 in Annex III, Part 1  396.  dithio-2,2-bispyridine-dioxide 1,1 (additive with trihydrated magnesium sulphate) - (pyrithione disulphide + magnesium sulphate)   397.  Colouring agent CI 12075 and its lakes, pigments and salts  398.  Colouring agent CI 45170 and CI 45170:1  399.  Lidocaine'2. In Annex III, Part 1, reference No 56 is added:   a  b  c  d  e  f         '56  Magnesium fluoride  Dental hygiene  products  0,15 % calculated as F when mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %   Contains magnesium  fluoride'        3. Annex III, Part 2  (a) reference Nos 1 and 4 are deleted;  (b) '31 December 1990' in the column 'Allowed until' is replaced by '31 December 1991' for the following number: 2. 1,1,1-Trichloroethane (methyl chloroform);  4. In Annex IV, Part 1, Nos 12075, 15585, 45170 and 45170:1 are deleted;  5. In Annex IV, Part 2:  (a) '31 December 1990' in the column 'Allowed until' is replaced by '31 December 1991' for Nos 26 100 and 73 900;  (b) the following colouring agent is added:  'Colour index No or denomination  Colour  Field of application   Other limitations and requirements  Allowed until       1  2  3  4             15 585 (3)  Red   ×    Maximum 3 % in the products intended to come into contact with mucous membranes   31. 12. 1991           (3) Lakes, pigments or salts of barium, strontium and zirconium insoluble in these colouring agents are also allowed. They must satisfy the insolubility test, which will be determined in accordance with the procedure provided for  in Article 8';   6. In Annex V, reference Nos 7 and 8 are deleted;  7. In Annex VI, Part 1, the following reference numbers are added:   a  b  c  d  e        '44  Alkyl (C12-C22) trimethyl ammonium, bromide and chloride (*)  0,1 %    45  4,4-dimethyl-1,3-oxazolidine  0,1 %  The pH of the finished product must not be lower than 6.'   46   N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-  imidazolidinyl-4)-N-(hydroxymethyl) urea  0,5 %         8. Annex VI, Part 2:  (a) '31. 12. 1990' in column (f) is replaced by '31. 12. 1991' for the following substances:  2. Ether p-chlorophenyl glycerol (Chlorphenesin)  15. Diisobutyl-phenoxy-ethoxy-ethyl dimethyl benzyl ammonium, chloride (+) (benzethonium chloride)  16. Alkyl (C8-C18) dimethylbenzyl ammonium chloride, bromide and saccharinate (+) (benzalkonium chloride, bromide and saccharinate)  20. 1,6-di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethioniate and p-hydroxybenzoate (+))  21. Benzylmiformal  27. Decyloxy-3-hydroxy-2amino-1 propane hydrochlorate (Decominol (DCI));  (b) reference Nos 4, 6 and 17 are deleted;  (c) the following reference number is added:   a  b  c  d  e  f         '28  7-Ethylbicyclooxa-  zolidine  0,3 %  Prohibited in dental hygiene products and in products intended to come into contact with mucous membranes   31 12. 1992'        9. In Annex VII, Part 1, the following reference number is added:   a  b  c  d  e        '7  3,3-(1,4-Phenylenedimethylidyne) bis  (7,7-dimethyl-2-oxo-bicyclo-(2,2,1) heptane-1-methane-sulphonic acid) and its salts  10 %  (expressed  in acid)  Prohibited in aerosols (sprays)'         Article 2  1. Regardless of the dates of admission mentioned in Article 1 (3) (b), (5) and (8) (a) and (c), Member States shall take all the necessary measures to ensure that as from 1 January 1992, for the substances mentioned in Article 1 (1),  and as from 1 January 1993, for the substances mentioned in Article 1 (2) to (9), neither manufacturers nor importers established in the Community shall place on the market products which do not comply with the requirements of this Directive.  2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 containing the substances mentioned in Article 1 (1) shall no longer be sold or otherwise surrendered to the final consumer after 31 December 1992  and that the products containing the substances mentioned in Article 1 (2) to (9) shall no longer be sold or surrendered to the final consumer after 31 December 1994, if they do not comply with the requirements of this Directive.  Article 3  1. Member States shall bring into force the laws, regulations and administrative provisions needed to comply with this Directive no later than 31 December 1991. They shall forthwith inform the Commission thereof.  2. When the Member States adopt these provisions these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.  3. Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive.  Article 4  This Directive is addressed to the Member States. Done at Brussels, 12 March 1991. For the Commission  Karel VAN MIERT  Member of the Commission  (1) OJ No L 262, 27. 9. 1976, p. 169. (2) OJ No L 71, 17. 3. 1990, p. 40.


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31979L0661

Council Directive 79/661/EEC of 24 July 1979 amending Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products

Official Journal L 192 , 31/07/1979 P. 0035 - 0035 Greek special edition: Chapter 13 Volume 8 P. 0179  Spanish special edition: Chapter 15 Volume 2 P. 0145  Portuguese special edition Chapter 15 Volume 2 P. 0145  Finnish special edition: Chapter 13 Volume 10 P. 0040  Swedish special edition: Chapter 13 Volume 10 P. 0040

COUNCIL DIRECTIVE  of 24 July 1979  amending Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products  (79/661/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,  Whereas Article 5 of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1) lays down that, on expiry of a three-year period from notification of the Directive, the substances and colouring agents listed in Annex IV thereof shall either be definitively permitted, or definitively prohibited, retained for a further period of three years in Annex IV, or deleted from all Annexes;  Whereas, in view of the complexity of the problems to be solved, this deadline cannot be met and must therefore be extended,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 76/768/EEC is hereby amended as follows:    1. In the first subparagraph of Article 5, the words "For a period of three years from notification of this Directive" shall be replaced by "Until 31 December 1980".       2. In the second subparagraph of Article 5, the words "On expiry of the three-year period" shall be replaced by "From 1 January 1981".          Article 2 Member States shall take all measures necessary to comply with this Directive by 30 July 1979. They shall forthwith inform the Commission thereof.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 24 July 1979.  For the Council  The President  M. O'KENNEDY  (1)OJ No L 262, 27.9.1976, p. 169.


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32003L0080

Commission Directive 2003/80/EC of 5 September 2003 establishing a symbol indicating the durability of cosmetic products in Annex VIIIa to Council Directive 76/768/EEC (Text with EEA relevance)

Official Journal L 224 , 06/09/2003 P. 0027 - 0028

Commission Directive 2003/80/ECof 5 September 2003establishing a symbol indicating the durability of cosmetic products in Annex VIIIa to Council Directive 76/768/EEC(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), as last amended by Directive 2003/15/EC of the European Parliament and of the Council(2),Having regard to Directive 2003/15/EC, in particular Article 1(11) thereof,Whereas:(1) In order to improve the information provided to consumers, cosmetic products should bear more precise indications concerning their durability.(2) For cosmetic products with a shelf life of 30 months or more, there should be an indication of the period of time after opening for which the product can be used without any harm to the consumer.(3) For this purpose, a symbol followed by the said period (in months and/or years) is provided for under Article 6(1)(c) of Council Directive 76/768/EEC.(4) The measures provided for by this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,HAS ADOPTED THIS DIRECTIVE:Article 1Annex VIIIa to Directive 76/768/EEC shall include the symbol which appears in the Annex to this Directive.Article 2Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 11 September 2004. 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 these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.Article 3This Directive shall enter into force on the third day following its publication in the Official Journal of the European Union.Article 4This Directive is addressed to the Member States.Done at Brussels, 5 September 2003.For the CommissionErkki LiikanenMember of the Commission(1) OJ L 262, 27.9.1976, p. 169.(2) OJ L 66, 11.3.2003, p. 26.ANNEXSymbol representing an open cream jar as provided for in Article 6(1)(c) of Council Directive 76/768/EEC(1).>PIC FILE= "L_2003224EN.002802.TIF">(1) OJ L 262, 27.9.1976, p. 169. Directive as last amended by Article 1(3) of Directive 2003/15/EC.


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31989L0679

Council Directive 89/679/EEC of 21 December 1989 amending for the fifth time Directive 76/768/EEC on the approximation of the laws of the member states relating to cosmetic products

Official Journal L 398 , 30/12/1989 P. 0025 - 0025 Finnish special edition: Chapter 13 Volume 19 P. 0123  Swedish special edition: Chapter 13 Volume 19 P. 0123

COUNCIL DIRECTIVEof 21 December 1989amending for the fifth time Directive 76/768/EEC on  the approximation of the laws of the Member States relating to cosmetic  products(89/679/EEC)THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article  100a thereof, Having regard to the proposal from the Commission (1), In cooperation with the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Directive 76/768/EEC (4), as last amended by Directive 88/667/EEC (5), establishes, for the  purposes of adapting technical requirements laid down by the Directive to technical progress, a  procedure for close cooperation between Member States and the Commission within a committee on the  adaptation to technical progress of the directives on the removal of technical barriers to trade in  the cosmetics products sector; Whereas, in the case of Annexes III to VII, the procedure involving that committee applies until 31  December 1988; whereas the period during which the procedure applies should be extended  indefinitely, HAS ADOPTED THIS DIRECTIVE: Article 1The second subparagraph of Article 8 (2) of Directive 76/768/EEC shall  be deleted. Article 2This Directive is addressed to the Member States. Done at Brussels, 21 December 1989. For the CouncilThe PresidentE. CRESSONOJ N° C 256,  9. 10. 1989, p. 68. (1) OJ N° C 214, 16. 8. 1988, p. 16. (2) OJ N° C 47, 27. 2. 1989, p. 81, and (3) OJ N° C 56, 6. 3. 1989, p. 1. (4) OJ N° L 262, 27. 9. 1976, p. 169. (5) OJ N° L 382, 21. 12. 1988, p. 46.


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32000L0011

Twenty-Fifth Commission Directive 2000/11/EC of 10 March 2000 adapting to technical progress Annex II to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance)

Official Journal L 065 , 14/03/2000 P. 0022 - 0025

TWENTY-FIFTH COMMISSION DIRECTIVE 2000/11/ECof 10 March 2000adapting to technical progress Annex II to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products(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), as last amended by Commission Directive 2000/6/EC(2), and in particular Article 8(2) thereof,Having regard to the consultation of the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers,Whereas:(1) It is an established fact that 3'-ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone or 7-acetyl-6-ethyl-1,1,4,4-tetramethyl-1,2,3,4-tetrahydronaphtalen is a substance that induces neurotoxic effects. This substance should therefore be prohibited in cosmetic products, and it should be listed in Annex II to the abovementioned Directive.(2) It is an established fact that aristolochic acid and its salts, as well as Aristolochia spp. and their preparations, are substances that act as powerful carcinogens. These substances should therefore be prohibited in cosmetic products, and they should be listed in the abovementioned Annex II.(3) It is an established fact that 2,3,7,8-tetra chlorodibenzo-p-dioxin is a toxic substance with powerful cancer-causing potential. This substance should therefore be prohibited in cosmetic products, and it should be listed in the abovementioned Annex II.(4) It is an established fact that 6-(piperidinyl)-2,4-pyrimidinediamine 3-oxide (minoxidil) and its salts are substances that produce powerful systemic vasodilating effects. Furthermore, a special scientific assessment needs to be made of minoxidil derivatives in order to determine their possible effects on health. Minoxidil and its salts should therefore be prohibited in cosmetic products, and they should be listed in the abovementioned Annex II.(5) It is an established fact that 3,4',5-tribromosalicylanilide is a substance that produces a powerful and prolonged photosensitising effect. This substance should therefore be prohibited in cosmetic products, and it should be listed in the abovementioned Annex II.(6) It is an established fact that Phytolacca spp. and their preparations are toxic substances that produce adverse pharmacological effects. These substances should therefore be prohibited in cosmetic products, and they should be listed in the abovementioned Annex II.(7) It is an established fact that 11α-hydroxypregn-4-ene-3, 20-dione) and its esters are substances that produce endocrine activity levels in correlation with powerful hypertension effects. These substances should therefore be prohibited in cosmetic products, and they should be listed in the abovementioned Annex II.(8) It is an established fact that the colouring agent C.I. 42 640 is a substance that produces carcinogenic effects. This substance should therefore be prohibited in cosmetic products, and it should be listed in the abovementioned Annex II.(9) It is an established fact that antiandrogens of steroidal structure are substances that interfere with the functioning of the androgene-dependent organs. These substances should therefore be prohibited in cosmetic products, and they should be listed in the abovementioned Annex II.(10) It is an established fact that zirconium and its compounds, other than the hydrated aluminium and zirconium hydroxychlorides and their complex with glycine and the zirconium lakes, pigments or salts of colouring agents that may be contained in the cosmetic products, are substances that produce mutagenic effects. These substances should therefore be prohibited in cosmetic products, and they should be listed in the abovementioned Annex II.(11) It is an established fact that tyrothricin and its salts are antibiotic substances with a bacteriostatic effect. These substances should therefore be prohibited in cosmetic products. However, as they are already listed under reference number 39 in the abovementioned Annex II, the allocation of a special reference number is not necessary.(12) It is an established fact that acetonitrile is a toxic solvent that produces acute systemic and potentially carcinogenic effects. This substance should therefore be prohibited in cosmetic products, and it should be listed in the abovementioned Annex II.(13) It is an established fact that tetrahydrozoline and its salts are substances that produce vasoconstrictive α-adrenergic effects. These substances should therefore be prohibited in cosmetic products, and they should be listed in the abovementioned Annex II.(14) In its judgment of 25 January 1994 (Angelopharm GmbH v Freie Hansestadt Hamburg) the Court of Justice of the European Communities invalidated the provisions of Article 1 of Twelfth Commission Directive 90/121/EEC(3) adapting to technical progress Annexes II, III, IV, V and VI to Directive 76/768/EEC referred to above, with a view to including the 11α-hydroxypregn-4-ene-3, 20-dione) and its esters on the list of substances that are prohibited in cosmetic products pursuant to the abovementioned Annex II. As grounds for its judgment, the Court ruled that the listing of this substance in the abovementioned Annex II should have been justified by a report from the Scientific Committee on Cosmetic Products and Non-Food Products but that no such justification had been provided.(15) In the light of this judgment, it follows that the listing of any substance in the abovementioned Annex II must, of necessity, be preceded by consultation of the Scientific Committee on Cosmetic Products and Non-Food Products. Consequently, steps must be taken under this Directive to rescind the listing of substances in the abovementioned Annex II resulting from the improper application of any Commission directive vitiated by the same procedural defect, namely Commission Directive 82/147/EEC(4), Fifth Commission Directive 84/415/EEC(5), Seventh Commission Directive 86/179/EEC(6), Ninth Commission Directive 87/137/EEC(7), Tenth Commission Directive 88/233/EEC(8), and Twelfth Directive 90/121/EEC.(16) In consequence of the abovementioned judgment of the Court of Justice of the European Communities, the reference numbers allocated to these substances improperly listed in the abovementioned Annex II should be formally withdrawn and, where appropriate, reintroduced on the list on the basis of a relevant scientific report delivered by the abovementioned Scientific Committee.(17) The measures laid down in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Cosmetic Products Sector,HAS ADOPTED THIS DIRECTIVE:Article 1Directive 76/768/EEC is hereby amended as indicated in the Annex to this Directive.Article 2Member States shall take any action needed to ensure that cosmetic products supplied to the final consumer do not contain any of the substances listed in Annex II to Directive 76/768/EEC, as defined in the Annex to this Directive.Article 3Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 June 2000 at the latest. They shall forthwith inform the Commission thereof.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.Article 4This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.Article 5This Directive is addressed to the Member States.Done at Brussels, 10 March 2000.For the CommissionErkki LIIKANENMember of the Commission(1) OJ L 262, 27.9.1976, p. 169.(2) OJ L 56, 1.3.2000, p. 42.(3) OJ L 71, 17.3.1990, p. 40.(4) OJ L 63, 6.3.1982, p. 26.(5) OJ L 228, 25.8.1984, p. 31.(6) OJ L 138, 24.5.1986, p. 40.(7) OJ L 56, 26.2.1987, p. 20.(8) OJ L 105, 26.4.1988, p. 11.ANNEXI. 1. Reference number 362 on the list in Annex II to Directive 76/768/EEC, as defined by Directive 82/147/EEC, is hereby deleted.2. Reference number 365 on the list in Annex II to Directive 76/768/EEC, as defined by Fifth Directive 84/415/EEC, is hereby deleted.3. Reference number 367 on the list in Annex II to Directive 76/768/EEC, as defined by Seventh Directive 86/179/EEC, and amended by Tenth Directive 88/233/EEC, is hereby deleted.4. Reference number 372 on the list in Annex II to Directive 76/768/EEC, as defined by Ninth Directive 87/137/EEC, is hereby deleted.5. Reference numbers 373 and 374 on the list in Annex II to Directive 76/768/EEC, as defined by Tenth Directive 88/233/EEC, are hereby deleted.6. Reference numbers 386, 390, 391, 392, 393 and 394 on the list in Annex II to Directive 76/768/EEC, as defined by Twelfth Directive 90/121/EEC, are hereby deleted.II. Annex II to Directive 76/768/EEC is amended as follows:The following reference numbers are added: "362. 3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone or 7-acetyl-6-ethyl-1,1,4,4-tetramethyl-1,2,3,4-tetrahydronaphtalen365. Aristolochic acid and its salts; Aristolochia spp. and their preparations367. 2,3,7,8-Tetra chlorodibenzo-p-dioxin372. 6-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide (minoxidil) and its salts373. 3,4',5-Tribromosalicylanilide374. Phytolacca spp. and their preparations385. 11[alpha   ]-Hydroxypregn-4-ene-3, 20-dione) and its esters386. Colouring agent C.I. 42 640390. Anti-androgens of steroidal structure391. Zirconium and its compounds, with the exception of the substances listed under reference number 50 in Annex III, Part One, and the zirconium lakes, pigments or salts of the colouring agents listed in Annex IV, Part One, with reference number 3393. Acetonitrile394. Tetrahydrozoline and its salts".


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31983L0201

Commission Directive 83/201/EEC of 12 April 1983 establishing exceptions from Council Directive 77/99/EEC for certain products which contain other foodstuffs and only a small percentage of meat or meat product

Official Journal L 112 , 28/04/1983 P. 0028 - 0030 Finnish special edition: Chapter 3 Volume 16 P. 0079  Spanish special edition: Chapter 03 Volume 27 P. 0157  Swedish special edition: Chapter 3 Volume 16 P. 0079  Portuguese special edition Chapter 03 Volume 27 P. 0157

*****COMMISSION  DIRECTIVE  of 12 April 1983  establishing exceptions from Council Directive 77/99/EEC for certain products which contain other foodstuffs and only a small percentage of meat or meat product  (83/201/EEC)  THE COMMISSION OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 77/99/EEC of 21 December 1976 on health problems affecting intra-Community trade in meat products (1), and in particular Article 8 thereof,  Whereas it may be decided in accordance with the procedure laid down in Article 18 of Directive 77/99/EEC that some provisions of that Directive shall not apply to certain products which contain other foodstuffs and only a small percentage of meat or meat products;  Whereas the percentage of fresh meat or meat product in products which contain other foodstuffs and only a small percentage of meat or meat product must be determined as a ratio of ingoing fresh meat or meat product to the final product; whereas, for certain products which contain other foodstuffs and only a small percentage of meat or meat product and which are dehydrated or concentrated at the production stage and ready to eat meals, the final product for this calculation is the product ready for use after preparation in accordance with the manufacturers instructions for use;  Whereas, after taking into account the nature and the composition of the products, exceptions may be allowed for certain products;  Whereas these exceptions may only relate to the conditions for approval of establishments as laid down in Chapter I of Annex A, the inspection requirements described in Chapters IV and V of Annex A, and the requirements for a health marking and health certificate as laid down in points 9 and 10 of Article 3 (1) of Directive 77/99/EEC; whereas, notwithstanding the provisions of this Directive, Member States must ensure that products which contain other foodstuffs and only a small percentage of meat or meat product intended for intra-Community trade are wholesome products prepared from fresh meat or meat products within the meaning of Directive 77/99/EEC;  Whereas products which contain other foodstuffs and only a small percentage of meat or meat product are manufactured either in establishments producing this type of product exclusively or in establishments producing, in addition to the abovementioned type of product, also meat products and/or other foodstuffs which do not contain meat or meat product; whereas these types of products can be prepared in separate parts of the same establishment;  Whereas establishments producing products which contain other foodstuffs and only a small percentage of meat or meat product, which fully comply with the provisions of Directive 77/99/EEC, must be allowed to avail themselves of the exceptions referred to in Article 8 (1) (c) of that Directive;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Veterinary Committee,  HAS ADOPTED THIS DIRECTIVE:  Article 1  This Directive lays down which provisions of Directive 77/99/EEC shall not apply, pursuant to Article 8 thereof, to certain products which contain other foodstuffs and only a small percentage of meat or meat products.  Article 2  Products which contain other foodstuffs and only a small percentage of meat or meat products shall mean products with not more than 10 % (w/w) of ingoing meat or meat product in relation to the final product ready for use after preparation in accordance with the manufacturers instructions for use.  Article 3  For approval of establishments manufacturing products which contain other foodstuffs and only a small percentage of meat or meat product:  1. The conditions laid down in Annex A, Chapter I of Directive 77/99/EEC shall only concern that part of the establishment where fresh meat or meat product is received, stored, handled and incorporated in the meat products and/or products which contain other foodstuffs and only a small percentage of meat or meat product, and where these products are processed and stored.  2. (a) In cases where the producer only uses products which have undergone complete treatment for the preparation of products which contain other foodstuffs and only a small percentage of meat or meat product, the competent authority may decide that the refrigeration rooms referred to under Annex A, Chapter I, paragraph 1 (a) (i) of Directive 77/99/EEC are not required.  (b) Provided that there is no deleterious effect on the fresh meat and meat products, the same room may be used for the operations to be carried out in separate rooms referred to in Annex A, Chapter I, paragraph 2 (a), (b), (c), (d), (e), (g) and (h) of Directive 77/99/EEC.  The exceptions under (a) and (b) apply only to that part of the establishment producing products which contain other foodstuffs and only a small percentage of meat or meat product.  3. If the establishment also manufactures other food products which do not contain meat or meat product, the rooms referred to in Annex A, Chapter I, paragraph 1 (c), (e), (i), (l), (n) and (o) and installations of (f), (g), (h) and (k) of Directive 77/99/EEC, which are required for products mentioned in Article 1 of this Directive, may be in common with the rooms and installations for the manufacture of the other food products which do not contain meat or meat product. However, the competent authority referred to under (6) in Article 3 (1) of Directive 77/99/EEC shall have access to these rooms and installations.  4. Member States shall ensure that the veterinary approval number of establishments or these parts of the establishments approved in accordance with this Directive is preceded by the figure 8 followed by a hyphen (i.e. '8-').  5. The veterinary approval number of establishments which fully comply with the provisions of Directive 77/99/EEC, may be preceded by the figure 8 followed by a hyphen (i.e. '8-') for the purpose of intra-Community trade in the products covered by this Directive.  Article 4  For products which contain other foodstuffs and only a small percentage of meat or meat product, Annex A, Chapter IV of Directive 77/99/EEC shall apply; however, for the purposes of paragraph 22, the competent authority shall decide upon the periods during which supervision shall be carried out. For this purpose the competent authority shall take into account the periods during which fresh meat or meat products and products which contain other foodstuffs and only a small percentage of meat or meat product are introduced, stored, handled and prepared in the establishments and the supervision shall only apply to the part of the establishment approved in accordance with this Directive.  The producer shall declare to the competent authority the periods during which fresh meat or meat products and products which contain other foodstuffs and only a small percentage of meat or meat product are introduced, stored, handled and prepared in his establishment.  Article 5  1. For establishments producing products which contain other foodstuffs and only a small percentage of meat or meat product, the health certificate provided for under (10) in Article 3 (1) of Directive 77/99/EEC shall not be required for these products if the health mark is completed by prefixing the number 8 followed by a hyphen (i.e. '8-') before the approval number of the establishment. 2. Member States shall inform the other Member States and the Commission of establishments making use of the provisions of paragraph 1.  Article 6  The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1984 and shall forthwith inform the Commission thereof.  Article 7  This Directive is addressed to the Member States.  Done at Brussels, 12 April 1983.  For the Commission  Poul DALSAGER  Member of the Commission  (1) OJ No L 26, 31. 1. 1977, p. 85.


title: Commission Directive 2007/70/EC of 29 November 2007 amending Directive 98/8/EC of the European Parliament and of the Council to include carbon dioxide as an active substance in Annex IA thereto (Text with EEA relevance)

text:
               30.11.2007

               EN

               Official Journal of the European Union

               L 312/26

         COMMISSION DIRECTIVE 2007/70/EC
   of 29 November 2007
   amending Directive 98/8/EC of the European Parliament and of the Council to include carbon dioxide as an active substance in Annex IA thereto
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2),
   Whereas:

               (1)

               Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market and amending Regulation (EC) No 1896/2000 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes carbon dioxide.

               (2)

               Pursuant to Regulation (EC) No 2032/2003, carbon dioxide has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC.

               (3)

               France was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 15 May 2006 in accordance with Article 10(5) and (7) of Regulation (EC) No 2032/2003.

               (4)

               The competent authority report has been reviewed by the Member States and the Commission. In accordance with Article 11(4) of Regulation (EC) No 2032/2003, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 21 June 2007, in an assessment report.

               (5)

               The review of carbon dioxide did not reveal any open questions or concerns to be addressed by the Scientific Committee on Health and Environmental Risks.

               (6)

               It appears from the various examinations made that biocidal products used as rodenticides and containing carbon dioxide may be expected to present only low risk to humans, animals and the environment and to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, in particular with regard to the uses which were examined and detailed in the assessment report. It is therefore appropriate to include carbon dioxide in Annex IA, in order to ensure that in all Member States authorisations or registrations for biocidal products used as rodenticides and containing carbon dioxide can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

               (7)

               It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance carbon dioxide and also to facilitate the proper operation of the biocidal products market in general.

               (8)

               A reasonable period should be allowed to elapse before an active substance is included in Annex IA in order to permit Member States and the interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

               (9)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations or registrations of biocidal products in product-type 14 containing carbon dioxide to ensure that they comply with Directive 98/8/EC.

               (10)

               Directive 98/8/EC should therefore be amended accordingly.

               (11)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex IA to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
   Article 2
   Transposition
   1.   Member States shall adopt and publish, by 31 October 2008 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 and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 November 2009.
   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 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, 29 November 2007.

            For the Commission

         Stavros DIMAS

            Member of the Commission

      (1)  OJ L 123, 24.4.1998, p. 1. Directive as last amended by Directive 2007/47/EC (OJ L 247, 21.9.2007, p. 21).

      (2)  OJ L 307, 24.11.2003, p. 1. Regulation as last amended by Regulation (EC) No 1849/2006 (OJ L 355, 15.12.2006, p. 63).

      ANNEX
      The following table with entry ‘No 1’ is inserted in Annex IA to Directive 98/8/EC:

                     ‘No

                     Common name

                     IUPAC name
                     Identification numbers

                     Minimum purity of the active substance in the biocidal product as placed on the market

                     Date of inclusion

                     Deadline for compliance with Article 16(3)
                     (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

                     Expiry date of inclusion

                     Product type

                     Specific provisions

                     1

                     Carbon dioxide

                     Carbon dioxide
                     EC No: 204-696-9
                     CAS No: 124-38-9

                     990  ml/l

                     1 November 2009

                     31 October 2011

                     31 October 2019

                     14

                     Only for use in ready-for-use gas canisters functioning together with a trapping device.

                        Note: For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm’


title: Commission Directive 2006/50/EC of  29 May 2006  amending Annexes IVA and IVB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market   (Text with EEA relevance)

text:
               30.5.2006

               EN

               Official Journal of the European Union

               L 142/6

         COMMISSION DIRECTIVE 2006/50/EC
   of 29 May 2006
   amending Annexes IVA and IVB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular Article 29 thereof,
   Whereas:

               (1)

               Annexes IVA and IVB to Directive 98/8/EC set out the requirements for the dossiers to be submitted by applicants for, respectively, inclusion of an active substance consisting of micro-organisms including viruses and fungi in Annex I or IA to that Directive, and authorisation of a biocidal product based on preparations of such micro-organisms including viruses and fungi.

               (2)

               It is necessary to adapt Annexes IVA and IVB to Directive 98/8/EC to technical progress and to developments in related legislation, in particular Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2) and Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (3), in order to provide a better basis for carrying out the risk assessments for micro-organisms and the biocidal products containing them. In addition, there have been scientific and technical developments within the field of microbiology and biotechnology. Providing for a similar structure of the data requirements in the framework of Directive 98/8/EC with those of Directive 91/414/EEC will facilitate the work of applicants submitting dossiers within both legal frameworks and the work of the Member States authorities evaluating such dossiers. It is therefore appropriate to update the data requirements for micro-organisms including viruses and fungi currently contained in Directive 98/8/EC and to align them as far as possible with those established in the framework of Directive 91/414/EEC.

               (3)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes IVA and IVB to Directive 98/8/EC are replaced by the text set out in 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 1 January 2008 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 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 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, 29 May 2006.

            For the Commission

         Stavros DIMAS

            Member of the Commission

      (1)  OJ L 123, 24.4.1998, p. 1. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

      (2)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/39/EC (OJ L 104, 13.4.2006, p. 30).

      (3)  OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).
   ANNEX
   ‘
         ANNEX IVA
         DATA SET FOR ACTIVE SUBSTANCES
         MICRO-ORGANISMS INCLUDING VIRUSES AND FUNGI

                     1.

                     For the purposes of this Annex, the term micro-organisms shall be understood as including also viruses and fungi. Dossiers on active micro-organisms shall address at least all the points listed under “Dossier requirements” below. For all micro-organisms subject to an application for inclusion into Annex I or IA, all available relevant knowledge and information in literature must be provided. The information related to the identification and characterisation of a micro-organism including mode of action is particularly important and must be entered in sections I to IV and provides the basis for an assessment of potential impacts on human health and of environmental effects.

                     2.

                     Where information is not necessary owing to the nature of the micro-organism Article 8(5) shall apply.

                     3.

                     A dossier within the meaning of Article 11(1) shall be prepared on strain level of the micro-organism unless information is submitted that shows that the species is known to be sufficiently homogeneous regarding all characteristics, or the applicant provides other arguments in accordance with Article 8(5).

                     4.

                     Where the micro-organism has been genetically modified within the meaning of Article 2(2) of Directive 2001/18/EC, a copy of the evaluation of the data concerning the assessment of the risks to the environment as established in Article 4(2) of that Directive, shall also be submitted.

                     5.

                     If the biocidal product action is known to be partly or entirely due to the effect of a toxin/metabolite, or if significant residues of toxins/metabolites are to be expected not related to the effect of the active micro-organism, a dossier for the toxin/metabolite shall be submitted in accordance with the requirements of Annexes IIA and, where specified, the relevant parts of Annex IIIA.

               Dossier requirements

            SECTIONS:

                     I.

                     Identity of the micro-organism

                     II.

                     Biological properties of the micro-organism

                     III.

                     Further information on the micro-organism

                     IV.

                     Analytical methods

                     V.

                     Effects on human health

                     VI.

                     Residues in or on treated materials, food and feed

                     VII.

                     Fate and behaviour in the environment

                     VIII.

                     Effects on non-target organisms

                     IX.

                     Classification and labelling

                     X.

                     Summary and evaluation of sections I to IX including conclusions of the risk assessment and recommendations

               The following data will be required to support submissions on the above points.
         I.   IDENTITY OF THE MICRO-ORGANISM
         1.1.   Applicant
         1.2.   Manufacturer
         1.3.   Name and species description, strain characterisation
         1.3.1.   Common name of the micro-organism (including alternative and superseded names)
         1.3.2.   Taxonomic name and strain indicating whether it is a stock variant, a mutant strain or a genetically modified organism (GMO); for viruses, taxonomic designation of the agent, serotype, strain or mutant
         1.3.3.   Collection and culture reference number where the culture is deposited
         1.3.4.   Methods, procedures and criteria used to establish the presence and identity of the micro-organism (e.g. morphology, biochemistry, serology, etc.)
         1.4.   Specification of the material used for manufacturing of formulated products
         1.4.1.   Content of the micro-organism
         1.4.2.   Identity and content of impurities, additives, contaminating micro-organisms
         1.4.3.   Analytical profile of batches
         II.   BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM
         2.1.   History of the micro-organism and its uses. Natural occurrence and geographical distribution
         2.1.1.   Historical background
         2.1.2.   Origin and natural occurrence
         2.2.   Information on target organism(s)
         2.2.1.   Description of the target organism(s)
         2.2.2.   Mode of action
         2.3.   Host specificity range and effects on species other than the target organism
         2.4.   Development stages/life cycle of the micro-organism
         2.5.   Infectiveness, dispersal and colonisation ability
         2.6.   Relationships to known plant or animal or human pathogens
         2.7.   Genetic stability and factors affecting it
         2.8.   Information on the production of metabolites (especially toxins)
         2.9.   Antibiotics and other anti-microbial agents
         2.10.   Robustness to environmental factors
         2.11.   Effects on materials, substances and products
         III.   FURTHER INFORMATION ON THE MICRO-ORGANISM
         3.1.   Function
         3.2.   Field of use envisaged
         3.3.   Product type(s) and category of users for which the micro-organism should be listed in Annex I, IA or IB
         3.4.   Method of production and quality control
         3.5.   Information on the occurrence or possible occurrence of the development of resistance of the target organism(s)
         3.6.   Methods to prevent loss of virulence of seed stock of the micro-organism
         3.7.   Recommended methods and precautions concerning handling, storage, transport or fire
         3.8.   Procedures for destruction or decontamination
         3.9.   Measures in case of an accident
         3.10.   Procedures for waste management
         3.11.   Monitoring plan to be used for the active micro-organism including handling, storage, transport and use
         IV.   ANALYTICAL METHODS
         4.1.   Methods for the analysis of the micro-organism as manufactured
         4.2.   Methods to determine and quantify residues (viable or non-viable)
         V.   EFFECTS ON HUMAN HEALTH
         TIER I
         5.1.   Basic information
         5.1.1.   Medical data
         5.1.2.   Medical surveillance on manufacturing plant personnel
         5.1.3.   Sensitisation/allergenicity observations
         5.1.4.   Direct observation, e.g. clinical cases
         5.2.   Basic studies
         5.2.1.   Sensitisation
         5.2.2.   Acute toxicity, pathogenicity, and infectiveness
         5.2.2.1.   Acute oral toxicity, pathogenicity and infectiveness
         5.2.2.2.   Acute inhalation toxicity, pathogenicity and infectiveness
         5.2.2.3.   Intraperitoneal/subcutaneous single dose
         5.2.3.   In vitro genotoxicity testing
         5.2.4.   Cell culture study
         5.2.5.   Information on short-term toxicity and pathogenicity
         5.2.5.1.   Health effects after repeated inhalatory exposure
         5.2.6.   Proposed treatment: first aid measures, medical treatment
         5.2.7.   Any pathogenicity and infectiveness to humans and other mammals under conditions of immunosuppression
         END OF TIER I
         TIER II
         5.3.   Specific toxicity, pathogenicity and infectiveness studies
         5.4.   Genotoxicity — In vivo studies in somatic cells
         5.5.   Genotoxicity — In vivo studies in germ cells
         END OF TIER II
         5.6.   Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation
         VI.   RESIDUES IN OR ON TREATED MATERIALS, FOOD AND FEED
         6.1.   Persistence and likelihood of multiplication in or on treated materials, feedingstuffs or foodstuffs
         6.2.   Further information required
         6.2.1.   Non-viable residues
         6.2.2.   Viable residues
         6.3.   Summary and evaluation of residues in or on treated materials, food and feed
         VII.   FATE AND BEHAVIOUR IN THE ENVIRONMENT
         7.1.   Persistence and multiplication
         7.1.1.   Soil
         7.1.2.   Water
         7.1.3.   Air
         7.2.   Mobility
         7.3.   Summary and evaluation of fate and behaviour in the environment
         VIII.   EFFECTS ON NON-TARGET ORGANISMS
         8.1.   Effects on birds
         8.2.   Effects on aquatic organisms
         8.2.1.   Effects on fish
         8.2.2.   Effects on freshwater invertebrates
         8.2.3.   Effects on algae growth
         8.2.4.   Effects on plants other than algae
         8.3.   Effects on bees
         8.4.   Effects on arthropods other than bees
         8.5.   Effects on earthworms
         8.6.   Effects on soil micro-organisms
         8.7.   Further studies
         8.7.1.   Terrestrial plants
         8.7.2.   Mammals
         8.7.3.   Other relevant species and processes
         8.8.   Summary and evaluation of effects on non-target organisms
         IX.   CLASSIFICATION AND LABELLING
         The dossier shall be accompanied by a reasoned proposals for allocating an active substance which is a micro-organism to one of the risk groups specified in Article 2 of Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (1) together with indications on the need for products to carry the biohazard sign specified in Annex II to that Directive.
         X.   SUMMARY AND EVALUATION OF SECTIONS I TO IX INCLUDING CONCLUSIONS OF THE RISK ASSESSMENT AND RECOMMENDATIONS

         ANNEX IVB
         DATA SET FOR BIOCIDAL PRODUCTS
         MICRO-ORGANISMS INCLUDING VIRUSES AND FUNGI

                     1.

                     For the purposes of this Annex, the term micro-organisms shall be understood as including also viruses and fungi. This Annex provides data requirements for the authorisation of a biocidal product based on preparations of micro-organisms. For all biocidal products based on preparations containing micro-organisms that are subject to application, all available relevant knowledge and information in literature should be provided. The information related to the identification and characterisation of all components in a biocidal product is particularly important and must be entered in sections I to IV and provides the basis for an assessment of possible impacts on human health and the environment.

                     2.

                     Where, information is not necessary owing to the nature of the biocidal product Article 8(5) shall apply.

                     3.

                     Information may be derived from existing data where a justification acceptable to the competent authority is provided. In particular, the provisions of Directive 67/548/EEC and Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (2) shall be used wherever possible to minimise animal testing.

                     4.

                     Where testing is done, a detailed description (specification) of the material used and its impurities, according to the provisions of Section II, must be provided. Where necessary, data as established in Annexes IIB, IIIB shall be required for all the toxicologically/eco-toxicologically relevant chemical components of the biocidal product, in particular if the components are substances of concern as defined in Article 2(1)(e).

                     5.

                     In cases where a new preparation is to be dealt with, extrapolation from Annex IVA, could be acceptable, provided that all the possible effects of the components, especially on pathogenicity and infectiveness, are evaluated.

               Dossier requirements

            SECTIONS:

                     I.

                     Identity of the biocidal product

                     II.

                     Physical, chemical and technical properties of the biocidal product

                     III.

                     Data on application

                     IV.

                     Further information on the biocidal product

                     V.

                     Analytical methods

                     VI.

                     Efficacy data

                     VII.

                     Effects on human health

                     VIII.

                     Residues in or on treated materials, food and feed

                     IX.

                     Fate and behaviour in the environment

                     X.

                     Effects on non-target organisms

                     XI.

                     Classification, packaging and labelling of the biocidal product

                     XII.

                     Summary and evaluation of sections I to XI including conclusions of the risk assessment and recommendations

               The following data will be required to support submissions on the above points.
         I.   IDENTITY OF THE BIOCIDAL PRODUCTS
         1.1.   Applicant
         1.2.   Manufacturer of the biocidal product and the micro-organism(s)
         1.3.   Trade name or proposed trade name, and manufacturer's development code number of the biocidal product
         1.4.   Detailed quantitative and qualitative information on the composition of the biocidal product
         1.5.   Physical state and nature of the biocidal product
         1.6.   Function
         II.   PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT
         2.1.   Appearance (colour and odour)
         2.2.   Storage stability and shelf-life
         2.2.1.   Effects of light, temperature and humidity on technical characteristics of the biocidal product
         2.2.2.   Other factors affecting stability
         2.3.   Explosivity and oxidising properties
         2.4.   Flash point and other indications of flammability or spontaneous ignition
         2.5.   Acidity, alkalinity and pH value
         2.6.   Viscosity and surface tension
         2.7.   Technical characteristics of the biocidal product
         2.7.1.   Wettability
         2.7.2.   Persistent foaming
         2.7.3.   Suspensibility and suspension stability
         2.7.4.   Dry sieve test and wet sieve test
         2.7.5.   Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules)
         2.7.6.   Emulsifiability, re-emulsifiability, emulsion stability
         2.7.7.   Flowability, pourability (rinsability) and dustability
         2.8.   Physical, chemical and biological compatibility with other products including biocidal products with which its use is to be authorised or registered
         2.8.1.   Physical compatibility
         2.8.2.   Chemical compatibility
         2.8.3.   Biological compatibility
         2.9.   Summary and evaluation of physical, chemical and technical properties of the biocidal product
         III.   DATA ON APPLICATION
         3.1.   Field of use envisaged
         3.2.   Mode of action
         3.3.   Details of intended use
         3.4.   Application rate
         3.5.   Content of micro-organism in material used (e.g. in the application device or bait)
         3.6.   Method of application
         3.7.   Number and timing of applications and duration of protection
         3.8.   Necessary waiting periods or other precautions to avoid adverse effects to human and animal health and the environment
         3.9.   Proposed instructions for use
         3.10.   Category of users
         3.11.   Information on the possible occurrence of the development of resistance
         3.12.   Effects on the materials or products treated with the biocidal product
         IV.   FURTHER INFORMATION ON THE BIOCIDAL PRODUCT
         4.1.   Packaging and compatibility of the biocidal product with proposed packaging materials
         4.2.   Procedures for cleaning application equipment
         4.3.   Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment
         4.4.   Recommended methods and precautions concerning: handling, storage, transport or fire
         4.5.   Measures in the case of an accident
         4.6.   Procedures for destruction or decontamination of the biocidal product and its packaging
         4.6.1.   Controlled incineration
         4.6.2.   Others
         4.7.   Monitoring plan to be used for the active micro-organism and other micro-organism(s) contained in the biocidal product including handling, storage, transport and use
         V.   ANALYTICAL METHODS
         5.1.   Methods for the analysis of the biocidal product
         5.2.   Methods to determine and quantify residues
         VI.   EFFICACY DATA
         VII.   EFFECTS ON HUMAN HEALTH
         7.1.   Basic acute toxicity studies
         7.1.1.   Acute oral toxicity
         7.1.2.   Acute inhalation toxicity
         7.1.3.   Acute percutaneous toxicity
         7.2.   Additional acute toxicity studies
         7.2.1.   Skin irritation
         7.2.2.   Eye irritation
         7.2.3.   Skin sensitisation
         7.3.   Data on exposure
         7.4.   Available toxicological data relating to non-active substances
         7.5.   Supplementary studies for combinations of biocidal products
         7.6.   Summary and evaluation of effects on human health
         VIII.   RESIDUES IN OR ON TREATED MATERIALS, FOOD AND FEED
         IX.   FATE AND BEHAVIOUR IN THE ENVIRONMENT
         X.   EFFECTS ON NON-TARGET ORGANISMS
         10.1.   Effects on birds
         10.2.   Effects on aquatic organisms
         10.3.   Effects on bees
         10.4.   Effects on arthropods other than bees
         10.5.   Effects on earthworms
         10.6.   Effects on soil micro-organisms
         10.7.   Additional studies on additional species or higher tier studies such as studies on selected non-target organisms
         10.7.1.   Terrestrial plants
         10.7.2.   Mammals
         10.7.3.   Other relevant species and processes
         10.8.   Summary and evaluation of effects on non-target organisms
         XI.   CLASSIFICATION, PACKAGING AND LABELLING OF THE BIOCIDAL PRODUCT
         As established in Article 20, proposals including justification for the classification and labelling of the biocidal product in accordance with the provisions set in Directive 67/548/EEC and Directive 1999/45/EC must be submitted. The classification comprises of the description of the category/categories of danger and qualifying risk phrases for all dangerous properties. On the basis of the classification, a proposal for labelling including the hazard symbol(s) and indications of danger, risk phrases and safety phrases should be given. The classification and labelling shall be in regard to the chemical substances contained in the biocidal product. If necessary, specimens of proposed packaging shall be submitted to the competent authority of a Member State.
         The dossier shall be accompanied by a reasoned proposal for allocation to one of the risk groups specified in Article 2 of Directive 2000/54/EC together with indications on the need for products to carry the biohazard sign specified in Annex II to that Directive.
         XII.   SUMMARY AND EVALUATION OF SECTIONS I TO XI INCLUDING CONCLUSIONS OF THE RISK ASSESSMENT AND RECOMMENDATIONS
      ’

      (1)  OJ L 262, 17.10.2000, p. 21.

      (2)  OJ L 200, 30.7.1999, p. 1. Directive as last amended by Commission Directive 2006/8/EC (OJ L 19, 24.1.2006, p. 12).