title: Commission Directive 2008/88/EC of 23 September 2008 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and III thereto to technical progress (Text with EEA relevance)

text:
               24.9.2008

               EN

               Official Journal of the European Union

               L 256/12

      COMMISSION DIRECTIVE 2008/88/EC
   of 23 September 2008
   amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and 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, replaced by the Scientific Committee on Consumer Products (SCCP), by Commission Decision 2004/210/EC (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 Scientific Committee on Consumer Products 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 no updated safety files are submitted allowing an adequate risk assessment should be included in Annex II to Directive 76/768/EEC.

               (5)

               Some hair dye substances have already been banned, either as a result of opinions by the SCCP or due to lack of safety data. The substances currently under consideration were carefully selected to be regulated together since they are listed in Annex IV. As no safety files on these substances for their use in hair dye products were submitted to the SCCP for a risk assessment by the agreed deadlines, there is no evidence that these substances, when used in hair dye products, can be considered safe for human health.

               (6)

               Substances without safety files 1-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) and its dihydrochloride salt; 1,4-Dihydroxybenzene (Hydroquinone); [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammoniumchloride (Basic Blue 26); Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulpho-nate (Ponceau SX) and 4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine and its hydrochloride salt (Basic Violet 14), currently listed as colorants in Annex IV and as hair dye substances in Annex III, Part 1 and Part 2, shall be deleted from Annex III and banned for use in hair dye products in Annex II.

               (7)

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

               (8)

               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
   Annexes II and III to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 14 February 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 and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 14 August 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 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, 23 September 2008.

            For the Commission

         Günter VERHEUGEN

            Vice-President

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

      (2)  OJ L 66, 4.3.2004, p. 45.

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

                  1.

                  in Annex II, the following reference numbers 1329 to 1369 are added:

                              Reference No

                              Chemical name/INCI-name

                              ‘1329

                              4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine (CAS 3248-93-9; EINECS 221-832-2) and its hydrochloride salt (Basic Violet 14; CI 42510) (CAS 632-99-5; EINECS 211-189-6) when used as a substance in hair dye products

                              1330

                              4-(2,4-Dihydroxyphenylazo)benzenesulphonic acid (CAS 2050-34-2; EINECS 218-087-0) and its sodium salt (Acid Orange 6; CI 14270) (CAS 547-57-9; EINECS 208-924-8) when used as a substance in hair dye products

                              1331

                              3-Hydroxy-4-(phenylazo)-2-naphthoic acid (CAS 27757-79-5; EINECS 248-638-0) and its calcium salt (Pigment Red 64:1; CI 15800) (CAS 6371-76-2; EINECS 228-899-7), when used as a substance in hair dye products

                              1332

                              2-(6-Hydroxy-3-oxo-(3H)-xanthen-9-yl)benzoic acid; Fluorescein (CAS 2321-07-5; EINECS 219-031-8) and its disodium salt (Acid yellow 73 sodium salt; CI 45350) (CAS 518-47-8; EINECS 208-253-0), when used as a substance in hair dye products

                              1333

                              4′,5′-Dibromo-3′,6′-dihydroxyspiro[isobenzofuran-1(3H),9′-[9H]xanthene]-3-one; 4′,5′-Dibromofluorescein; (Solvent Red 72) (CAS 596-03-2; EINECS 209-876-0) and its disodium salt (CI 45370) (CAS 4372-02-5; EINECS 224-468-2) when used as a substance in hair dye products

                              1334

                              2-(3,6-Dihydroxy-2,4,5,7-tetrabromoxanthen-9-yl)-benzoic acid; Fluorescein, 2′,4′,5′,7′-tetrabromo-; (Solvent Red 43) (CAS 15086-94-9; EINECS 239-138-3), its disodium salt (Acid Red 87; CI 45380) (CAS 17372-87-1; EINECS 241-409-6) and its aluminium salt (Pigment Red 90:1 Aluminium lake) (CAS 15876-39-8; EINECS 240-005-7) when used as a substance in hair dye products

                              1335

                              Xanthylium, 9-(2-carboxyphenyl)-3-(2-methylphenyl)amino)-6-((2-methyl-4-sulfophenyl)amino)-, inner salt (CAS 10213-95-3); and its sodium salt (Acid Violet 9; CI 45190) (CAS 6252-76-2; EINECS 228-377-9) when used as a substance in hair dye products

                              1336

                              3′,6′-Dihydroxy-4′,5′-diiodospiro(isobenzofuran-1(3H),9′-[9H]xanthene)-3-one; (Solvent Red 73) (CAS 38577-97-8; EINECS 254-010-7) and its sodium salt (Acid Red 95; CI 45425) (CAS 33239-19-9; EINECS 251-419-2) when used as a substance in hair dye products

                              1337

                              2′,4′,5′,7′-Tetraiodofluorescein (CAS 15905-32-5; EINECS 240-046-0), its disodium salt (Acid Red 51; CI 45430) (CAS 16423-68-0; EINECS 240-474-8) and its aluminium salt (Pigment Red 172 Aluminium lake)(CAS 12227-78-0; EINECS 235-440-4) when used as a substance in hair dye products

                              1338

                              1-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) (CAS 95-86-3; EINECS 202-459-4) and its dihydrochloride salt (2,4-Diaminophenol HCl) (CAS 137-09-7; EINECS 205-279-4) when used as a substance in hair dye products

                              1339

                              1,4-Dihydroxybenzene (Hydroquinone) (CAS 123-31-9; EINECS 204-617-8) when used as a substance in hair dye products

                              1340

                              [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (Basic Blue 26; CI 44045) (CAS 2580-56-5; EINECS 219-943-6) when used as a substance in hair dye products

                              1341

                              Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (Ponceau SX; CI 14700) (CAS 4548-53-2; EINECS 224-909-9) when used as a substance in hair dye products

                              1342

                              Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-) (Acid Green 1; CI 10020) (CAS 19381-50-1; EINECS 243-010-2) when used as a substance in hair dye products

                              1343

                              4-(Phenylazo)resorcinol (Solvent Orange 1; CI 11920) (CAS 2051-85-6; EINECS 218-131-9) and its salts, when used as a substance in hair dye products

                              1344

                              4-[(4-Ethoxyphenyl)azo]naphthol (Solvent Red 3; CI 12010) (CAS 6535-42-8; EINECS 229-439-8) and its salts, when used as a substance in hair dye products

                              1345

                              1-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol (Pigment Red 4; CI 12085) (CAS 2814-77-9; EINECS 220-562-2) and its salts when used as a substance in hair dye products

                              1346

                              3-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide (Pigment Red 112; CI 12370) (CAS 6535-46-2; EINECS 229-440-3) and its salts when used as a substance in hair dye products

                              1347

                              N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide (Pigment Red 5; CI 12490) (CAS 6410-41-9; EINECS 229-107-2) and its salts when used as a substance in hair dye products

                              1348

                              Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (Pigment Red 48; CI 15865) (CAS 3564-21-4; EINECS 222-642-2) when used as a substance in hair dye products

                              1349

                              Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate (Pigment Red 63:1; CI 15880) (CAS 6417-83-0; EINECS 229-142-3) when used as a substance in hair dye products

                              1350

                              Trisodium 3-hydroxy-4-(4′-sulphonatonaphthylazo)naphthalene-2,7-disulphonate (Acid Red 27; CI 16185) (CAS 915-67-3; EINECS 213-022-2) when used as a substance in hair dye products

                              1351

                              2,2′-[(3,3′-Dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] (Pigment Yellow 13; CI 21100) (CAS 5102-83-0; EINECS 225-822-9) when used as a substance in hair dye products

                              1352

                              2,2′-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] (Solvent Yellow 29; CI 21230) (CAS 6706-82-7; EINECS 229-754-0) when used as a substance in hair dye products

                              1353

                              1-((4-Phenylazo)phenylazo)-2-naphthol (Solvent Red 23; CI 26100) (CAS 85-86-9; EINECS 201-638-4) when used as a substance in hair dye products

                              1354

                              Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate (Food Black 2; CI 27755) (CAS 2118-39-0; EINECS 218-326-9) when used as a substance in hair dye products

                              1355

                              Ethanaminium, N-(4-((4-(diethylamino)phenyl)(2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, sodium salt (Acid Blue 1; CI 42045) (CAS 129-17-9; EINECS 204-934-1) when used as a substance in hair dye products

                              1356

                              Ethanaminium, N-(4-((4-(diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, calcium salt (2:1) (Acid Blue 3; CI 42051) (CAS 3536-49-0; EINECS 222-573-8) when used as a substance in hair dye products

                              1357

                              Benzenemethanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)(4-hydroxy-2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt (Fast Green FCF; CI 42053) (CAS 2353-45-9; EINECS 219-091-5) when used as a substance in hair dye products

                              1358

                              1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline (Solvent Yellow 33; CI 47000) (CAS 8003-22-3; EINECS 232-318-2) when used as a substance in hair dye products

                              1359

                              Nigrosine (CI 50420) (CAS 8005-03-6) when used as a substance in hair dye products

                              1360

                              8,18-Dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3′,2′-m]triphenodioxazine (Pigment Violet 23; CI 51319) (CAS 6358-30-1; EINECS 228-767-9) when used as a substance in hair dye products

                              1361

                              1,2-Dihydroxyanthraquinone (Pigment Red 83; CI 58000) (CAS 72-48-0; EINECS 200-782-5) when used as a substance in hair dye products

                              1362

                              Trisodium 8-hydroxypyrene-1,3,6-trisulphonate (Solvent Green 7; CI 59040) (CAS 6358-69-6; EINECS 228-783-6) when used as a substance in hair dye products

                              1363

                              1-Hydroxy-4-(p-toluidino)anthraquinone (Solvent Violet 13; CI 60725) (CAS 81-48-1; EINECS 201-353-5), when used as a substance in hair dye products

                              1364

                              1,4-bis(p-Tolylamino)anthraquinone (Solvent Green 3; CI 61565) (CAS 128-80-3; EINECS 204-909-5) when used as a substance in hair dye products

                              1365

                              6-Chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one (VAT Red 1; CI 73360) (CAS 2379-74-0; EINECS 219-163-6) when used as a substance in hair dye products

                              1366

                              5,12-Dihydroquino[2,3-b]acridine-7,14-dione (Pigment Violet 19; CI 73900) (CAS 1047-16-1; EINECS 213-879-2) when used as a substance in hair dye products

                              1367

                              (29H,31H-Phthalocyaninato(2-)-N29,N30,N31,N32)copper (Pigment Blue 15; CI 74160) (CAS 147-14-8; EINECS 205-685-1) when used as a substance in hair dye products

                              1368

                              Disodium [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cuprate(2-) (Direct Blue 86; CI 74180) (CAS 1330-38-7; EINECS 215-537-8) when used as a substance in hair dye products

                              1369

                              Polychloro copper phthalocyanine (Pigment Green 7; CI 74260) (CAS 1328-53-6; EINECS 215-524-7) when used as a substance in hair dye products’

                  2.

                  Annex III is amended as follows:

                              (a)

                              in Part 1, reference number 10 is deleted;

                              (b)

                              in Part 1, column c of reference number 14, item (a) is deleted;

                              (c)

                              in Part 2, reference numbers 57, 59 and 60 are deleted.


Avis juridique important

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32002L0099

Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption

Official Journal L 018 , 23/01/2003 P. 0011 - 0020

Council Directive 2002/99/ECof 16 December 2002laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumptionTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 37 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 European Economic and Social Committee(3),Whereas:(1) In the context of the single market, specific animal health rules have been laid down to govern intra-Community trade in the production, processing, distribution and introduction from third countries of products of animal origin for human consumption included in Annex I to the Treaty.(2) Those rules have allowed the removal of obstacles to trade in the products concerned, thereby contributing to the creation of the internal market whilst ensuring a high level of animal health protection.(3) The aim of those rules is to prevent the introduction or spread of animal diseases resulting from the placing on the market of products of animal origin. They also contain common provisions concerning in particular the restrictions applicable to the placing on the market of products coming from a holding or area infected by epizootic diseases and the obligation to subject products coming from restricted areas to treatment to destroy the disease agent.(4) Those common provisions should be harmonised in order to remove possible inconsistencies introduced when the specific animal health rules were adopted. Such harmonisation will also ensure uniform implementation of animal health rules throughout the Community and introduce greater transparency in the structure of Community legislation.(5) Veterinary checks on products of animal origin intended for trade must be carried out in accordance with Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market(4). Directive 89/662/EEC contains safeguard measures that may be implemented in the event of a serious hazard to animal health.(6) Products imported from third countries must not present an animal health hazard for Community livestock.(7) To that end, procedures should be introduced to prevent the introduction of epizootic diseases. Such procedures include a regular evaluation of the animal health situation in the third countries concerned.(8) Procedures must also be introduced for establishing general or specific rules or criteria to be applied to imports of products of animal origin.(9) Provisions concerning the importation of meat of domestic ungulates and meat products prepared from or with such meat are already contained in Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries(5).(10) The procedures applicable to the importation of meat and meat products can be used as a model for the importation of other products of animal origin.(11) Veterinary checks on products of animal origin imported into the Community from third countries must be carried out in accordance with Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries(6); Directive 97/78/EC contains safeguard measures that may be implemented in case of a serious hazard to animal health.(12) Account must be taken of the guidelines laid down by the World Organisation for Animal Health (OIE) when adopting rules for international trade.(13) Community audits and inspections must be organised in order to ensure the uniform application of the animal health provisions.(14) The products covered by this Directive are listed in Annex I to the Treaty.(15) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7),HAS ADOPTED THIS DIRECTIVE:Article 1ScopeThis Directive lays down the general animal health rules governing all stages of the production, processing and distribution within the Community and the introduction from third countries of products of animal origin and products obtained therefrom intended for human consumption.These rules do not affect the provisions laid down in Directives 89/662/EEC and 97/78/EC and the Directives listed in Annex I.Article 2DefinitionsFor the purposes of this Directive, the definitions in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(8) and Directive 97/78/EC shall apply as necessary. The following definitions shall also apply:1. "all stages of the production, processing and distribution" means any stage from and including the primary production of a food of animal origin, up to and including its storage, transport, sale or supply to the final consumer;2. "introduction" means the bringing of goods into one of the territories listed in Annex I to Directive 97/78/EC for the purpose of placing them under the customs procedures referred to in Article 4(16)(a) to (f) of Council Regulation (EC) No 2913/92 of 12 October 1992 establishing the Community Customs Code(9);3. "official veterinarian" means a veterinarian qualified to act in that capacity appointed by the competent authority;4. "products of animal origin" means products obtained from animals and products obtained therefrom, for human consumption, including live animals where they are prepared for such use.CHAPTER IANIMAL HEALTH REQUIREMENTS APPLICABLE TO ALL STAGES OF THE PRODUCTION, PROCESSING AND DISTRIBUTION OF PRODUCTS OF ANIMAL ORIGIN WITHIN THE COMMUNITYArticle 3General animal health requirements1. Member States shall take measures to ensure that at all stages of the production, processing and distribution of products of animal origin within the Community, food business operators do not cause the spread of diseases transmissible to animals, in accordance with the following provisions.2. Products of animal origin must be obtained from animals which fulfil the animal health conditions laid down by the relevant Community legislation.3. Products of animal origin shall be obtained from animals:(a) which do not come from a holding, establishment, territory or part of a territory subject to animal health restrictions applicable to the animals and products concerned, under the rules set out in Annex I;(b) which, in the case of meat and meat products, were not slaughtered in an establishment in which animals infected or suspected of being infected with one of the diseases covered by the rules referred to in (a), or carcasses or parts thereof of such animals, were present during the slaughtering or production process, unless such suspicion has been ruled out;(c) which, in the case of aquaculture animals and products, comply with Directive 91/67/EEC(10).Article 4Derogations1. Notwithstanding Article 3 and subject to compliance with the disease control measures referred to in Annex I, Member States may authorise the production, processing and distribution of products of animal origin which come from a territory or part of a territory subject to animal health restrictions but which do not come from a holding which is infected or suspected of being infected, provided that:(i) before being subjected to the treatment referred to below, the products have been obtained, handled, transported and stored separately, or at different times, from products fulfilling all the animal health conditions, and the conditions for transport out of the territory subject to animal health restrictions have been approved by the competent authority;(ii) the products which are to undergo treatment are clearly identified;(iii) the products undergo treatment enabling the animal health problem concerned to be eliminated, and(iv) the treatment is applied at an establishment approved for that purpose by the Member State in which the animal health problem occurred.The provisions of the first subparagraph shall be applied in accordance with Annexes II and III(1) hereto, or with detailed rules to be adopted in accordance with the procedure referred to in Article 12(2).2. The production, processing and distribution of aquaculture products not complying with the conditions laid down in Article 3 shall be authorised, subject to the conditions laid down in Directive 91/67/EEC and, where necessary, in accordance with further conditions to be adopted in accordance with the procedure referred to in Article 12(2).3. Furthermore, where the health situation so permits, derogations from Article 3 may be granted in certain situations, in accordance with the procedure referred to in Article 12(2). In such cases, particular account shall be taken of:(a) the specific characteristics of the disease in the species concerned, and(b) any tests or measures to which the animals must be subjected.Where such derogations are granted, steps must be taken to ensure that the degree of protection from animal disease will in no way be impaired. Any measures needed to ensure the protection of animal health in the Community shall therefore be adopted in accordance with the same procedure.Article 5Veterinary certificates1. Member States shall ensure that products of animal origin intended for human consumption are subjected to veterinary certification where:- provisions adopted for animal health reasons under Article 9 of Directive 89/662/EEC require products of animal origin from a Member State to be accompanied by a health certificate, or- a derogation has been granted under Article 4(3).2. Under the procedure referred to in Article 12(2), detailed implementing rules, and in particular a model for such certificates, may be drawn up taking into account the general principles set out in Annex IV. Certificates may include details required in accordance with other Community public and animal health legislation.Article 6Official veterinary controls1. Pending adoption of Regulations of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and rules for controls applicable to foodstuffs and animal feed, Member States shall ensure that official animal health controls are carried out by their competent authorities to ensure compliance with this Directive, its implementing rules and any safeguard measures relating to products of animal origin adopted pursuant to this Directive. As a general rule, inspections must be unannounced and checks carried out in accordance with the provisions of Directive 89/662/EEC.2. Pending adoption of Regulations of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin and rules for controls applicable to foodstuffs and animal feed, where infringements of animal health rules are identified, Member States shall take the necessary measures to remedy the situation in accordance with the provisions of Directive 89/662/EEC.3. Experts from the Commission may carry out on-the-spot checks, including audits, in cooperation with the competent authorities of the Member States, insofar as is necessary for the uniform application of this Directive. The Member States in whose territory checks are made shall provide the experts with all the assistance necessary for carrying out their duties. The Commission shall inform the competent authority of the results of the checks made.If a serious animal health risk is identified during a Commission audit or inspection, the Member State concerned shall immediately take all measures necessary to safeguard animal health. If such measures are not taken, or if they are considered to be insufficient, the Commission shall, in accordance with the procedure referred to in Article 12(2), take the measures necessary to safeguard animal health and inform the Member States thereof.4. The rules for the application of this Article, and in particular those governing the procedure for cooperation with the national authorities, shall be adopted in accordance with the procedure referred to in Article 12(2).CHAPTER IIIMPORTS FROM THIRD COUNTRIESArticle 7General provisionsMember States shall take measures to ensure that products of animal origin intended for human consumption are introduced from third countries only if they comply with the requirements of Chapter I applicable to all stages of the production, processing and distribution of such products in the Community or if they offer equivalent animal health guarantees.Article 8Compliance with Community rulesIn order to ensure compliance with the general obligation laid down in Article 7, the following shall be established in accordance with the procedure referred to in Article 12(2):1. Lists of the third countries or regions of third countries from which imports of specified products of animal origin are permitted. A third country shall appear on such lists only if a Community audit of that country has taken place and demonstrates that the competent veterinary authority provides appropriate guarantees as regards compliance with Community legislation.When drawing up or updating those lists, particular account shall be taken of:(a) the legislation of the third country;(b) the organisation of the competent veterinary authority and its inspection services in the third country, the powers of these services, the supervision to which they are subject, and the means at their disposal, including staff capacity, to apply their legislation effectively;(c) the actual animal health requirements applying to the production, manufacture, handling, storage and dispatch of products of animal origin intended for the Community;(d) the assurances which the competent veterinary authority of the third country can give regarding compliance or equivalence with the relevant animal health conditions;(e) any experience of marketing the product from the third country and the results of any import controls carried out;(f) the results of Community inspections and/or audits carried out in the third country, in particular the results of the assessment of the competent authorities or, where the Commission so requests, the report submitted by the competent authorities of the third country on the inspections which they have carried out;(g) the health status of livestock, other domestic animals and wildlife in the third country, with particular regard to exotic animal diseases and any aspects of the general health situation in the country which might pose a risk to public or animal health in the Community;(h) the regularity, speed and accuracy with which the third country supplies information on the existence of infectious or contagious animal diseases in its territory, particularly the notifiable diseases listed by the World Organisation for Animal Health (OIE) or, in the case of diseases of aquaculture animals, the notifiable diseases listed in the Aquatic Animal Health Code of the OIE;(i) the rules on the prevention and control of infectious or contagious animal diseases in force in the third country and their implementation, including rules on imports from other countries.2. The Commission shall arrange for up-to-date versions of all lists drawn up or updated in accordance with this Article to be available to the public. Lists drawn up in accordance with this Article may be combined with other lists drawn up for animal and public health purposes and may also include models of health certificates.3. Rules of origin for products of animal origin and the animals from which such products are obtained shall be established in accordance with the procedure referred to in Article 12(2).4. Special import conditions for each third country or group of third countries, having regard to the animal health situation of the third country or countries concerned shall be established in accordance with the procedure referred to in Article 12(2).5. Where necessary:- the detailed rules for the application of this Article,- criteria for classifying third countries and regions thereof with regard to animal diseases, and- specific rules concerning types of introduction or particular products, such as the introduction of products by travellers or the introduction of commercial samples,may be established in accordance with the procedure referred to in Article 12(2).Article 9Documents1. A veterinary certificate meeting the requirements set out in Annex IV shall be presented with consignments of products of animal origin upon their entry into the Community.2. The veterinary certificate shall certify that the products satisfy:(a) the requirements laid down for such products under this Directive and under the Community legislation laying down animal health requirements or provisions that are equivalent to those requirements; and(b) any special import conditions established in accordance with the procedure referred to in Article 12(2).3. Documents may include details required under other provisions of Community public and animal health legislation.4. In accordance with the procedure referred to in Article 12(2):(a) provision may be made for the use of electronic documents,(b) model documents may be drawn up,(c) rules and certification for transit may be established.Article 10Community inspections and audits1. Community inspections and/or audits at all stages covered by this Directive may be carried out in third countries by experts from the Commission in order to verify conformity with or equivalence to Community animal health rules. The experts from the Commission may be accompanied by experts from the Member States authorised by the Commission to carry out these inspections and/or audits.2. The inspections and/or audits in third countries referred to in paragraph 1 shall be carried out on behalf of the Community, and the Commission shall meet the costs incurred.3. The procedure for carrying out the inspections and/or audits in third countries referred to in paragraph 1 may be established or modified in accordance with the procedure referred to in Article 12(2).4. If a serious animal health risk is identified during a Community inspection or audit, the Commission shall immediately take the measures necessary to safeguard animal health, in accordance with Article 22 of Directive 97/78/EC, and inform the Member States thereof.CHAPTER IIIFINAL PROVISIONSArticle 11Update of technical annexesThe annexes hereto may be amended in accordance with the procedure referred to in Article 12(2) in order to take account in particular of:(i) scientific opinions and scientific knowledge, particularly concerning new risk assessments;(ii) technical developments; and(iii) the setting of safety targets for animal health.Article 12Committee procedure1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up by Article 58 of Regulation (EC) No 178/2002.2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its rules of procedure.Article 13Transitional provisions1. As from the date referred to in Article 14(1), the animal health rules laid down by the Directives listed in Annex V shall no longer apply.2. Implementing rules adopted on the basis of such provisions shall remain in force until they are replaced by rules having the same effect adopted on the basis of this Directive.3. Transitional measures may be laid down in accordance with the procedure referred to in Article 12(2).Article 141. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 2005. They shall forthwith inform the Commission thereof.When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for making such reference shall be adopted by the Member States.2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.Article 15This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.Article 16This Directive is addressed to the Member States.Done at Brussels, 16 December 2002.For the CouncilThe PresidentM. Fischer Boel(1) OJ C 365 E, 19.12.2000.(2) Opinion of the European Parliament delivered on 15 May 2002.(3) Opinion of the Economic and Social Committee delivered on 28 March 2001.(4) OJ L 395, 30.12.1989, p. 13. Directive as last amended by Directive 92/118/EEC (OJ L 62, 15.3.1993, p. 49).(5) OJ L 302, 31.12.1972, p. 28. Directive as last amended by Regulation (EC) No 1452/2001 (OJ L 198, 21.7.2001, p. 11).(6) OJ L 24, 30.1.1998, p. 9.(7) OJ L 184, 17.7.1999, p. 23.(8) OJ L 31, 1.2.2002, p. 1.(9) OJ L 302, 19.10.1992, p. 1. Regulation as last amended by Regulation (EC) No 2700/2000 (OJ L 311, 12.12.2000, p. 17).(10) OJ L 46, 19.2.1991, p. 1.ANNEX IDiseases of relevance to trade in products of animal origin and for which control measures have been introduced under Community legislation>TABLE>ANNEX IISpecial identification mark for meat from a territory or a part of a territory1. The health mark for fresh meat must bear a diagonal cross consisting of two straight lines intersecting at the centre of the stamp and enabling the information thereon to remain legible.2. The mark mentioned in paragraph 1 may also be applied using a single oval stamp, 6,5 cm wide by 4,5 cm high; the following information must appear on the mark in perfectly legible characters:- on the upper part, the name or ISO code of the Member State in capitals: AT, BE, DE, DK, ES, FI, FR, GR, IE, IT, LU, NL, PT, SE and UK,- in the centre, the veterinary approval number of the slaughterhouse,- on the lower part, one of the following sets of initials CE, EC, EF, EG, EK or EY,- two straight lines crossing at the centre of the stamp in such a way that the information is not obscured.The letters must be at least 0,8 cm high and the figures at least 1 cm high.The stamp must also carry information whereby the veterinarian who inspected the meat can be identified.The mark must be applied under the direct supervision of the official veterinarian controlling the implementation of the animal health requirements.ANNEX III1. Treatments to eliminate certain animal health risks linked to meat and milk>TABLE>+: Effectiveness recognised.0: Effectiveness not recognised.ANNEX IVGeneral principles of certification1. The representative of the competent authority of dispatch issuing a certificate to accompany a consignment of products of animal origin must sign the certificate and ensure that it bears an official stamp. This requirement applies to each sheet of the certificate if it consists of more than one.2. Certificates must be drawn up in the official language or languages of the Member State of destination and those of the Member State in which the border inspection takes place, or be accompanied by a certified translation into that language or those languages. However, a Member State may consent to the use of an official Community language other than its own.3. The original version of the certificate must accompany consignments on entry into the Community.4. Certificates must consist of:(a) a single sheet of paper; or(b) two or more pages that are part of a single and indivisible sheet of paper; or(c) a sequence of pages numbered so as to indicate that it is a particular page in a finite sequence (for example, "page 2 of 4 pages").5. Certificates must bear a unique identifying number. Where the certificate consists of a sequence of pages, each page must indicate this number.6. The certificate must be issued before the consignment to which it relates leaves the control of the competent authority of the country of dispatch.ANNEX V1. Council Directive 72/461/EEC of 12 December 1972 on health problems affecting intra-Community trade in fresh meat(1), as last amended by the Act of Accession of Austria, Finland and Sweden.2. Council Directive 80/215/EEC of 22 January 1980 on animal health problems affecting intra-Community trade in meat products(2), as last amended by the Act of Accession of Austria, Finland and Sweden.3. Council Directive 91/494/EEC of 26 June 1991 on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultrymeat(3), as last amended by Directive 93/121/EC.4. Council Directive 91/495/EEC of 27 November 1990 concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat(4), as last amended by the Act of Accession of Austria, Finland and Sweden.5. Council Directive 92/45/EEC of 16 June 1992 on public health and animal health problems relating to the killing of wild game and the placing on the market of wild-game meat(5), as last amended by Directive 97/79/EC.6. Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products(6).7. Council Directive 94/65/EC of 14 December 1994 laying down the requirements for the production and placing on the market of minced meat and meat preparations(7).(1) OJ L 302, 31.12.1972, p. 24.(2) OJ L 47, 21.2.1980, p. 4.(3) OJ L 268, 24.9.1991, p. 35.(4) OJ L 268, 24.9.1991, p. 41.(5) OJ L 268, 14.9.1992, p. 35.(6) OJ L 268, 14.9.1992, p. 1.(7) OJ L 368, 31.12.1994, p. 10.


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31972L0461

Council Directive 72/461/EEC of 12 December 1972 on health problems affecting intra-Community trade in fresh meat

Official Journal L 302 , 31/12/1972 P. 0024 - 0027 Finnish special edition: Chapter 3 Volume 5 P. 0057  Danish special edition: Series I Chapter 1972(31.12)L291 P. 0073  Swedish special edition: Chapter 3 Volume 5 P. 0057  English special edition: Series I Chapter 1972(31.12)L302 P. 0003  Greek special edition: Chapter 03 Volume 8 P. 0236  Spanish special edition: Chapter 03 Volume 6 P. 0167  Portuguese special edition Chapter 03 Volume 6 P. 0167

COUNCIL DIRECTIVE  of 12 December 1972  on health problems affecting intra-Community trade in fresh meat  (72/461/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;  Having regard to the Opinion of the European Parliament;  Having regard to the Opinion of the Economic and Social Committee;  Whereas the implementation of the Council Directive of 26 June 1964 1 on health problems affecting intra-Community trade in fresh meat, as last amended by the Council Directive of 27 October 1970, 2 will not have the desired effect so long as intra-Community trade is hindered by differences between the health requirements of Member States concerning meat ; whereas to eliminate such differences the health provisions of the Member States concerning meat must be approximated;  Whereas in particular, to improve information concerning the state of health of the animals from which fresh meat for consignment to another Member State comes, it should be stipulated that animals from certain categories must have stayed for a specified period in the territory of the Community, unless an exception is granted by the country of destination and communicated to the other Member States and the Commission;  Whereas, in order to avoid the spread of epizootic diseases by means of fresh meat, fresh meat from animals coming from a holding or area which, in accordance with Community rules, has been placed under health restrictions, should be excluded from intra-Community trade;  Whereas care should be taken that fresh meat which does not comply with Community rules should not be given the health mark provided for in those rules;  Whereas the Member States must have the right to prohibit the introduction of meat into their territory if it does not comply with Community health provisions ; whereas, however, the consignor should at his own request or upon request of a representative be allowed to return the meat unless on health grounds there are reasons to the contrary;  Whereas the consignor or his representative and the competent authorities of the exporting country must be informed of the reasons for any prohibition or restriction so that they may be aware of them;  Whereas the Member States must have the right to prohibit the introduction into their territory of fresh meat from a Member State where an epizootic disease has broken out ; whereas, depending on the nature and character of this epizootic disease, such a prohibition may either be limited to meat coming from a part of the territory of the exporting country, or extended to the whole of that territory ; whereas, in the event of an outbreak of a contagious disease in the territory of a Member State it is necessary for appropriate measures to be taken rapidly to control it ; whereas the dangers inherent in such diseases and the requisite protective measures should be viewed in the same light throughout the Community ; whereas, to this end, the Standing Veterinary Committee set up by the Council Decision of 15 October 1968 3 should institute an emergency Community procedure to take the necessary measures;  1OJ No 121, 29.7.1964, p. 2012/64. 2OJ No L 239, 30.10.1970, p. 42. 3OJ No L 255, 28.10.1968, p. 23.   Whereas it seems desirable to set down in this Directive the general principle of non-discrimination ; whereas it should accordingly be expressly laid down, pending specific Community rules covering imports from third countries, that the treatment to be applied to third countries by each Member State should not be more favourable than the treatment applied, pursuant to this Directive, to trade between the Member States;  HAS ADOPTED THIS DIRECTIVE:    Article 1 1. This Directive shall apply to intra-Community trade in fresh meat of domestic bovine animals, swine, sheep and goats and solipeds.  2. All parts of these animals which are fit for human consumption shall be considered to be meat.  3. All meat which has not undergone any preserving process shall be considered as fresh meat ; however, for the purposes of this Directive chilled and frozen meat shall be considered to be fresh meat.   Article 2 For the purposes of this Directive:    (a) official veterinarian means the veterinarian designated by the competent central authority of the Member State;       (b) exporting country means the Member State from which fresh meat is sent to another Member State;       (c) country of destination means the Member State to which fresh meat is sent from another Member State.          Article 3 Only fresh meat which fulfils the following requirements may be sent from the territory of one Member State to the territory of another Member State:    (a) Meat obtained from domestic sheep, goats or solipeds must, without prejudice to Article 6, come from animals which have stayed in the territory of the Community for at least twenty-one days immediately prior to slaughter or from birth in the case of animals less than twenty-one days old.       (b) The meat must not have been obtained from animals which come from a holding or area which for health reasons is subject to prohibition pursuant to Article 3 (2) (b) of the Council Directive of 26 June 1964 1 on animal health problems affecting intra-Community trade in bovine animals and swine, last amended by the Council Directive of 7 February 1972 2, as a result of the outbreak of foot and mouth disease, swine fever or contagious swine paralysis (Teschen disease) to which the animals in question are susceptible.       (c) The meat must not be obtained from slaughterhouses in which cases of foot and mouth disease, swine fever or contagious swine paralysis (Teschen disease) have been recorded.         Should there be an outbreak of one of these diseases, the Member States shall ensure that no meat suspected to be contaminated forms part of intra-Community trade.   Article 4 Without prejudice to Article 3 (b), fresh meat from swine, sheep and goats may not be sent to the territory of another Member State except on condition that such animals do not come from a holding in the exporting country which is subject to prohibition for health reasons as a result of the outbreak of porcine, ovine or caprine brucellosis.  Such prohibition must last at least six weeks after the last case has been officially recorded.   Article 5 1. The Member States shall ensure that fresh meat obtained from animals which do not fulfil the requirements of Articles 3 and 4 shall not be given the health mark provided for in Chapter IX of Annex I of the Directive on health problems affecting intra-Community trade in fresh meat.  2. The country of destination may prohibit the introduction of fresh meat into its territory if it has been established that Articles 3 and 4 have not been observed.  1OJ No 121, 29.7.1964, p. 1977/64. 2OJ No L 38, 12.2.1972, p. 95.   3. In this event, the country of destination must authorise, at the request of the consignor or his representative, the return of the whole consignment of fresh meat, provided this is not contrary to considerations of health.  4. The competent authority of the country of destination may order the consignment to be destroyed where introduction is prohibited, pursuant to paragraph 2, and the exporting country or country of transit, as the case may be, does not authorise return.  5. For the application of the measures referred to in paragraphs 2, 3 and 4 of this Article, Article 6 (7) of the Directive on health problems affecting intra-Community trade in bovine animals and swine shall apply.   Article 6 1. Countries of destination may grant to one or more exporting countries general authorisations or authorisations restricted to specific cases for the introduction into their territory of fresh meat, in derogation from Article 3 (a) does not come from animals which have stayed in the territory of the Community for at least twenty-one days immediately prior to slaughter or since birth in the case of animals less than twenty-one days old.  2. When a country of destination grants a general authorisation, in accordance with paragraph 1, it shall immediately inform the Member States and the Commission.  3. When a country of destination grants one of the authorisations provided for in paragraph 1, a corresponding authorisation should be obtained, in cases of transit, from the countries of transit concerned.   Article 7 1. Without prejudice to Articles 3, 4 and 6, a Member State may, if there is a danger that animal diseases may be spread by the introduction into its territory of fresh meat from another Member State, take the following measures:    (a) In the event of an outbreak of an epizootic disease in the other Member State, it may temporarily prohibit or restrict the introduction of meat from the affected areas of that Member State;       (b) If an epizootic disease becomes widespread or if there is an outbreak of another serious contagious or infections animal disease, it may temporarily prohibit or restrict the introduction of meat from the entire territory of that State.         2. Each Member State must notify the other Member States and the Commission without delay of the outbreak in its territory of any disease referred to in paragraph 1 and of the measures it has taken to control it. It must also notify them without delay of the disappearance of the disease.  3. Measures taken by a Member State under paragraph 1, and their repeal, must be communicated without delay to the other Member States and to the Commission together with the precise reasons for such measures.  It may be decided, according to the procedure laid down in Article 8, that these measures should be amended, mainly to ensure coordination with those adopted by the other Member States, or abolished.  4. If the situation provided for in paragraph 1 arises and if it seems necessary for other Member States also to apply the measures taken pursuant to the said paragraph, together with any amendments made in accordance with paragraph 3, the appropriate provisions shall be adopted according to the procedure defined in Article 8.  5. Article 8 of the Directive on health problems affecting intra-Community trade in fresh meat is hereby repealed.   Article 8 1. Where the procedure laid down in this Article is to be followed, matters shall be referred by the Chairman, either on his own initiative or at the request of a Member State, to the Standing Veterinary Committee (hereinafter called "the Committee") set up by the Council Decision of 15 October 1968.  2. Within the Committee the votes of the Member States shall be weighted as provided in Article 148 (2) of the Treaty. The Chairman shall not vote.  3. The representative of the Commission shall submit a draft of the measures to be adopted. The Committee shall deliver its Opinion on the measures within two days. Opinions shall be delivered by a majority of twelve votes.  4. The Commission shall adopt measures which shall apply immediately, where they are in accordance with the Opinion of the  Committee. However, if these measures are not in accordance with the Opinion of the Committee or if the Committee does not give an Opinion, the Commission shall forthwith submit a proposal to the Council concerning the measures to be taken. The Council shall adopt the measures by a qualified majority.  If after fifteen days from the date on which it was informed, the Council has not adopted the measures, the Commission shall adopt the proposed measures and shall implement them immediately, unless the Council has decided against the said measures by a simple majority.   Article 9 Article 8 shall apply for eighteen months from the date on which the Committee was first informed, either pursuant to Article 8 (1) or on the basis of any similar regulation.   Article 10 Until Community provisions relating to importation of fresh meat from third countries are implemented, national provisions relating to fresh meat imported from those countries shall not be more favourable than those resulting from this Directive.   Article 11 The Member States shall bring into force the measures necessary to comply with this Directive before 1 January 1974 and shall forthwith inform the Commission thereof.   Article 12 This Directive is addressed to the Member States.     Done at Brussels, 12 December 1972.  For the Council  The President  P. LARDINOIS