title: Commission Directive 2013/5/EU of 14 February 2013 amending Directive 98/8/EC of the European Parliament and of the Council to include pyriproxyfen as an active substance in Annex I thereto  Text with EEA relevance

text:
               15.2.2013

               EN

               Official Journal of the European Union

               L 44/14

         COMMISSION DIRECTIVE 2013/5/EU
   of 14 February 2013
   amending Directive 98/8/EC of the European Parliament and of the Council to include pyriproxyfen as an active substance in Annex I thereto
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   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) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1451/2007 of 4 December 2007 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 (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 pyriproxyfen.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, pyriproxyfen has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive.

               (3)

               The Netherlands were designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 2 October 2009 in accordance with Article 10(5) and (7) of Regulation (EC) No 1451/2007.

               (4)

               The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 21 September 2012, in an assessment report.

               (5)

               It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing pyriproxyfen may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include pyriproxyfen for use in product type 18 in Annex I to that Directive.

               (6)

               Not all potential uses and exposure scenarios have been evaluated at Union level, which, in particular, included only professional use. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

               (7)

               In the light of the findings in the assessment report that there is a possible indirect human exposure via consumption of food as a result of those uses represented in the assessment, it is appropriate to require, where relevant, verification of the need to set new or to amend existing maximum residue levels in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (3) or with Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (4). Measures should be adopted ensuring that the applicable maximum residue levels are not exceeded.

               (8)

               In view of the assumptions made during the risk assessment, it is appropriate to require that products authorised for professionals are used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to workers and operators can be reduced to an acceptable level.

               (9)

               In view of the risks identified for the environment, it is appropriate to require that products are not authorised for direct use on surface water, unless it can be demonstrated in the application for product authorisation that risks to the aquatic and terrestrial ecosystems and groundwater can be reduced to an acceptable level, and that any authorisation of products intended to be used in waste treatment facilities is subject to appropriate risk mitigation measures to avoid contamination of the area outside the waste treatment site.

               (10)

               The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product-type 18 containing the active substance pyriproxyfen and also to facilitate the proper operation of the biocidal products market in general.

               (11)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and 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.

               (12)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

               (13)

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

               (14)

               In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (5), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

               (15)

               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 I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 31 January 2014 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 February 2015.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 14 February 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

      (2)  OJ L 325, 11.12.2007, p. 3.

      (3)  OJ L 152, 16.6.2009, p. 11.

      (4)  OJ L 70, 16.3.2005, p. 1.

      (5)  OJ C 369, 17.12.2011, p. 14.

      ANNEX
      In Annex I to Directive 98/8/EC, the following entry is added:

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

                     Minimum degree of purity of the active substance (1)

                     Date of inclusion

                     Deadline for compliance with Article 16(3), unless one of the exceptions indicated in the footnote to this heading applies (2)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (3)

                     ‘62

                     pyriproxyfen

                     4-phenoxyphenyl (RS)-2-(2-pyridyloxy)propyl ether
                     EC No: 429-800-1
                     CAS No: 95737-68-1

                     970 g/kg

                     1 February 2015

                     31 January 2017

                     31 January 2025

                     18

                     The Union level risk assessment did not address all potential uses and exposure scenarios; certain uses and exposure scenarios, such as use by non-professionals, were excluded. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
                     For products containing pyriproxyfen that may lead to residues in food or feed, Member States shall verify the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.
                     Member States shall ensure that authorisations are subject to the following conditions:

                                 (1)

                                 Products authorised for professionals shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level by other means.

                                 (2)

                                 Products shall not be authorised for direct use on surface water, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level.

                                 (3)

                                 Products intended to be used in waste treatment facilities shall be subject to appropriate risk mitigation measures to avoid contamination of the area outside the waste treatment site.’

         (1)  The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 11. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated substance.

         (2)  For products containing more than one active substance covered by Article 16(2), the deadline for compliance with Article 16(3) is that of the last of its active substances to be included in this Annex. For products for which the first authorisation has been granted later than 120 days before the deadline for compliance with Article 16(3) and a complete application has been submitted for mutual recognition in accordance with Article 4(1) within 60 days of the granting of the first authorisation, the deadline for compliance with Article 16(3) in relation to that application is extended to 120 days after the date of reception of the complete application for mutual recognition. For products for which a Member State has proposed to derogate from mutual recognition in accordance with Article 4(4), the deadline for compliance with Article 16(3) is extended to 30 days after the date of the Commission Decision adopted in accordance with the second subparagraph of Article 4(4).

         (3)  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


Avis juridique important

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31988L0658

Council Directive 88/658/EEC of 14 December 1988 amending Directive 77/99/EEC on health problems affecting intra-Community trade in meat products

Official Journal L 382 , 31/12/1988 P. 0015 - 0033 Finnish special edition: Chapter 3 Volume 28 P. 0076  Swedish special edition: Chapter 3 Volume 28 P. 0076

COUNCIL DIRECTIVE of 14 December 1988 amending Directive 77/99/EEC on health problems affecting intra-Community trade in meat products (88/658/EEC)   THE COUNCIL OF THE EUROPEAN COMMUNITIES,   Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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 Commitee (3),   Whereas, as a result of the adoption by the Council of Directive 83/90/EEC of 7 February 1983 amending Directive 64/433/EEC on health problems affecting intra-Community trade in fresh meat (4), Directive 77/99/EEC (5), as last amended by Regulation  (EEC) No 3805/87 (6), should be amended in order to harmonize the rules applicable to meat and meat products;   Whereas Directive 77/99/EEC should be amended also in order to take accounr of scientific and technical developments;   Wheres rules should be established for prepared meals in which meat products form part of the composition;   Whereas some meat products should remain excluded from the scope of the Directive;   Whereas it has proved necessary to make provision for hygiene rules to be followed with regard to containers,   Whereas meat products intended for direct sale to the consumer must be labelled in accordance with Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and  advertising of foodstuffs for.sale to the ultimate consumer (7), as last amended by Directive 86/197/EEC;       Whereas the procedures governing the inspection and approval of, and the withdrawal of approval from, establishments, and the procedure to be followed in the event of a dispute between Member States must be amended in order to harmonize them with the  rules laid down in other directives in the veterinary field;   Whereas the rules relating to inspections must take account of the essential requirements of the internal market;   Whereas it has been established that all the Member States have national rules governing the composition of meat products and limiting the additives that may be used for the manufacture of meat products; whereas the existence of different standards in  this field may run counter to the essential requirements of the internal market; whereas a procedure should therefore be provided for whereby these standards concerning composition may be harmonized; whereas it is appropriate that the laying down of  common rules governing the use of additives for meat products should be postponed until a decision is taken within the framework of the Community;   Whereas Annex A to this Directive lays down the temperatures to be observed during cutting and wrapping of meat products; whereas the reference to a procedure for establishing those temperatures may thus be deleted;   Whereas provisions relating to animal health problems were laid down in Council Directive 80/215/EEC of 22 January 1980 on animal health problems affecting intra-Community trade in meat products (8), as last amended by lirective 87/491/EEC (9)  HAS ADOPTED THIS DIRECTIVE:     Article 1 Articles 1 to 17 of Directive 77/99/EEC are hereby replaced by the following:   ´Article 1  This Directive lays down health requirements for meat products intended for intra-Community trade.       Without prejudice to prohibitory measures to be taken pursuant to Directive 80/215/EEC (10), this Directive shall not apply to meat products:   (a) forming part of travellers' personal luggage, on condition that they are not subsequently used for commercial purposes;   (b) sent as small packages to private persons, in so far as no commercial operation is involved;   (c) intended for consumption by the crew and passengers on board means of transport operating commercially between Member States.       Article 2  For the purposes of this Directive the following definitions shall apply:   (a) Meat products: products prepared from or with meat which has undergone treatment such that the cut surface shows that the product no longer has the characteristics of fresh meat.   However, the following shall not be regarded as a meat product:   (i) meat which has undergone only cold treatment; such meat shall remain subject to the rules in Directive 64/433/EEC;   (ii) products not covered by the definition in the first subparagraph; such products shall be subject to Council Directive 88/657/EEC of 14 December 1988 laying down the requirements for the production of, and trade in, minced meat, meat in pieces of  less than 100 grams and meat preparations and amending Directives 64/433/EEC, 71/118/EEC and 72/462/EEC (11).       In addition, the following are not covered by this Directive:   (i) meat extracts, meat consommé and stock, meat sauces and simi1ar products not containing fragments of meat;   (ii) whole, broken or crushed bones, meat peptones, animal gelatin, meat powder, pork-rind powder, blood plasma, dried blood, dried blood plasma, cellular proteins, bone extracts and similar products;   (iii) fats melted down from animal tissues;   (iv) stomachs, bladders and intestines, cleaned and bleached, salted or dried,   (b)  (i) meat: meat as defined in:   - Article 1 of Directive 64/433/EEC,   - Article 1 of Directive 71/118/EEC,   - Article 1 of Directive 72/461/EEC,   - Article 2 of Directive 72/462/EEC,   - Article 2 of Directive 88/657/EEC;   (ii) fresh meat: fresh meat as defined in Article 1 of  Directives 64/433/EEC, 71/118/EEC and 72/461/EEC and in Article 2 of Directive 72/462/EEC and also meat satisfying the requirements set out in Article 3 of Directive 88/657/EEC;   (c) meat preparations: preparations satisfying the requirements set out in Article 3 of Directive 88/657/EEC;   (d) treatment: the treatment of fresh meat, whether or not combined with other foodstuffs, by heating, salting, curing or drying, or a combination of these processes;   (e) heating: use of dry or damp heat;   (f) salting: use of salt;   (g) curing: distribution of curing salts throughout the product;   (h) maturing: complete treatment of salted meat, applied under climatic conditions which, in the course of a slow and gradual reduction of humidity, are capable of generating natural fermentation or enzymatic processes, involving changes over a period  of time which give the product typical organoleptic characteristics and ensure its preservation and wholesomeness at normal ambient temperature;   (i) drying: natural or artifical reduction of the water content;   (j) prepared meals: wrapped meat products corresponding to culinary preparations, cooked or pre-cooked, with no preservatives added for the purposes of preservation;   (k) exporting country: the Member State from which meat products are sent to another Member State;   (l) country of destination: the Member State to which meat products are sent from another Member State;   (m) consignment: a quantity of a meat product which is covered by the same health certificate;   (n) wrapping: the protection of meat products by the use of an initial wrapping or initial container in direct contact with the product concerned as well as the initial wrapper or initial container itself;   (o) packaging:the placing of one or more wrapped or unwrapped meat products in a container, as well as the container itself;   (p) hermetically-sealed container: container intended to protect the contents against the entry of micro-organisms during and after heat processing and which is impermeable to air.   Article 31. Each Member State shall ensure that only meat products complying with the following general conditions - without prejudice to the conditions laid down in paragraph 3 - are sent from its territory to the territory of another Member State:   (1) they shall have been prepared in an establishment approved and inspected in accordance with Article 7;   (2) they shall have been prepared, stored and transported in accordance with Annex A and if they are stored in a cold-storage plant separate from the establishment, this plant must be approved and inspected io accordance with Article 8 of Directive  64/433/EEC;   (3) they shall have been prepared from:   (a) fresh meat as defined in Article 2 (b)  (ii). This fresh meat may originate:   (i) in accordance with Directives 64/433/EEC and 71/118/EEC, in the Member State in which the preparation is carried out or in any other Member State. Pigmeat recognized as trichinous may not be used to manufacture meat products;   (ii) in accordance with Article 5 a of Directive 72/46l/EEC, in the Member State in which the preparation is carried out;   (iii) in accordance with Directive 72/462/EEC, in a third country, being imported either directly or by way of another Member State;   (iv) in accordance with Article 15 of Directive 71/118/EEC, in a third country in so far as:   - products obtained from this meat fulfil the requirements set out in this Directive,   - these products do not bear the health marking laid down in Annex A, Chapter VI,   - intra-Community trade in these products remains subject to the national provisions of each Member State;   (b) meat referred to in Article 5 (a) of Directive 64/433/EEC;   (4) they shall have been prepared from fresh meat complying with the conditions of Annex A, Chapter III;   (5) they shall, in accordance with Annex A, Chapter IV, have undergone an inspection carried out by the competent authority and, in the case of hermetically-sealed containers, carried out in accordance with rules to be drawn up under the procedure laid  down in Article 18 by not later than 31 March 1990;   (6) they shall meet the requirements laid down in Article 4;   (7) where wrapping and packaging takes place, they must be wrapped and packaged in accordance with Annex A, Chapter V;   (8) they shall bear a health marking in accordance with Annex A, Chapter VI;   (9) they shall, in accordance with Annex A, Chapter VII, be accompanied by a health certificate during transport to the country of destination. This obligation shall not apply to meat products in hermetically sealed containers and having undergone a  treatment such as referred to in Annex B, Chapter II, point 1 (a), first indent, if the health mark is indelibly marked on the container in accordance with the provisions to be drawn up under the procedure laid down in Article 18;   (10) they shall be stored and transported to the country of destination under satisfactory health conditions in accordance with Annex A, Chapter VIII.   2. Meat products may not have been subjected to ionizing radiation unless this is justified on medical grounds and unless such procedure is clearly indicated on the product and on the health certificate.   3. Member States shall ensure that, in addition to the general requirements laid down in paragraphs 1 and 2, meat products meet the following conditions:   (a) they shall have been prepared by heating, curing or drying, which process may be combined with smoking or maturing, possibly under specific microclimatic conditions, and associated, in particular, with certain curing agents within the meaning of  Article 13. They may also be associated with other foodstuffs and condiments;   (b) they may have been obtained from a meat product or from a meat preparation.   Article 4For inspection purposes, the producer shall ensure that the packaging of meat products, which cannot be stored at ambient temperatures and meat preparations, bear a clear and legible indication of the temperature at which the products must be  transported and stored, and the minimum durability date.   Article 5 Articles 3 and 4 shall not apply to meat products which are imported with the authorization of the country of  destination for uses other than human consumption; in this case, the country of destination shall ensure that these products are used only for  the purposes for which they were dispatched to that country.   Article 6Member States shall ensure that intra-Community trade in prepared meals is governed by the provisions laid down for meat products and that such meals also meet the requirements set out in Annex B, Chapter III.   Article 71. Each Member State shall draw up a list of its approved establishments, each of them having a veterinary approval number. It shall send this list to the other Member States and to the Commission.   A Member State shall not approve an establishment unless it complies with this Directive. The Member State shall withdraw its approval if the conditions for approval cease to be fulfilled.   If a check has been made in accordance with Article 8, the Member State concerned shall take account of the conclusions resulting from that check. The other Member States and the Commission shall be informed in the event of approval being withdrawn.   2. The inspection and supervision of approved establishments shall be carried out by the competent authority.   The competent authority must at all times have free access to all parts of establishments for the purpose of ensuring that this Directive is being complied with.   3. Where a Member State considers, in particular after carrying out a check or inspection as provided for in Article 12 (1) and (2), that the provisions governing approval are not being, or have ceased to be, observed in an establishment in another  Member State, it shall inform the competent central authority of that State accordingly. That authority shall take all necessary measures and notify the competent central authority of the first Member State of the decisions taken and the reasons  therefore.   Should that Member State fear that such measures have not been taken or are inadequate, it shall, with the Member State in question, seek ways and means of remedying the situation, if appropriate, by an on-the-spot-visit.   The Member State concerned shall inform the Commission of the matters in dispute and of the solutions reached.   If the Member States in question cannot reach agreement, one of them shall within a reasonable period put the matter before the Commission, which shall instruct one or more veterinary experts to give an opinion. In the light of that opinion or of the  opinion expressed in accordance with Article 8, Member States may be authorized, under the procedure laid down in Article 18, to prohibit provisionally the introduction into their territory of meat products coming from the particular establishment  concerned. Such authorization may be withdrawn, under the procedure laid down in Article 18, in the light of a further opinion drawn up by one or more veterinary experts.   The veterinary experts must be nationals of a Member State other than one of those involved in the dispute.   General rules for the application of this paragraph shall be adopted in accordance with the procedure laid down in Article 18.   Article 8he provisions of Article 9 of Directive 64/433/EEC shall apply mutatis mutandis to the establishments referred to in Article 7.   Article 9By way of derogation from the conditions stipulated in Article 3, it may be decided, in accordance with the procedure laid down in Article 18, that some provisions of this Directive shall not apply to certain products which contain other  foodstuffs and only a small percentage of meat, meat product or meat preparation.   These exceptions shall relate only to:   (a) the conditions for approval of establishments as laid down in Annex A, Chapter I and in Annex B, Chapter I;   (b) the inspection requirements described in Annex A, Chapter IV;   (c) the requirements for a health marking and health certificate as laid down in paragraphs 8 and 9 of Article 3 (1).   When considering whether to allow exceptions such as those provided for under this Article, both the nature and the composition of the product shall be taken into account.   Notwithstanding the provisions of this Article, Member States shall ensure that all meat products intended for intra-Community trade are wholesome products prepared from fresh meat, meat products or products. covered by Directive 88/657/EEC.   Article 10The Council shall, acting by a qualified majority on a proposal from the Commission to be submitted by 1 July 1990, adopt the rules applicable to the products referred to in Article 2 (a), third subparagraph.   Article 11  Member States shall ensure that the meat products undergo checks to be carried out by the establishments referred to in Article 7 and with periodic inspection by the official department, in order to ensure that the products comply with the requirements  laid down in this Directive.   Article 121. Without prejudice to Articles 7 and 8, a country of destination may check that all consignments of meat products, excluding meat products referred to in Article 3 (1)  (9), second sentence, are accompanied by the health certificate in  accordance with Chapter VII of Annex A.   2. If irregularities are seriously suspected, the country of destination may carry out non-discriminatory inspections to check that the requirements laid down in this Directive have been met.   3. As a general rule, checks and inspections shall be carried out at the place of destination of the goods or at any other suitable place, provided that the choice of the latter place causes as little interference as possible with the movement of the  goods.   The checks and inspections referred to in paragraphs 1 and 2 may not be such as to cause undue delay in the movement of the goods and their placing on the market which might adversely affect the quality of the meat products.   4. If, during an inspection carried out on the basis of paragraph 2, it is found that the meat products do not comply with the requirements of this Directive, the competent authority of the country of destination may give the consignor, the consignee or  their representative the option of sending back the products and preparations or using them for other purposes, provided that health considerations so permit, or, if they do not, of destroying the consignment. In any event, precautionary measures shall  be taken to prevent improper use of such meat products.   5. (a) Decisions of the competent authority, together with the grounds for taking them, shall be communicated to the consignor or his representative. Should such person so request, the grounds for taking the decisions shall be communicated forthwith in  writing, accompanied by an indication of the channels of appeal open under current legislation, the forms they take and the time limits within which they are open.   (b) If the decisions referred to in (a) are based on the diagnosis of a contagious or infectious disease or a deterioration dangerous to human health, they shall be communicated forthwith to the competent central authority of the producing Member State  and to the Commission.   (c) Following such communication, appropriate measures may be taken in accordance with the procedure laid down in Article 18, in particular for the purpose of coordinating the measures taken in other Member States with regard to the meat products  involved.   Article 13Pending compilation, in the context of Community legislation on additives, of the list of foodstuffs to which the additives authorized for use may be added and establishment of the conditions under which they may be added and, where  appropriate, a limit on the technological purpose of their use, the national rules and the bilateral arrangements existing on the date on which this Directive is brought into application restricting the use of additives in the products covered by this  Directive shall remain applicable, with due regard for the general provisions of the Treaty, provided that they apply without distinction to domestic production and to trade.   Until that provisional list is drawn up, the national rules and the bilateral arrangements governing the use of additives for the products referred to in this Directive shall remain in force, in compliance with the general provisions of the Treaty and  the Community rules in force in the field of additives.   Article 14The Annexes shall be amended by the Council acting by a qualified majority on a proposal from the Commission.   Article 15The Council shall, acting on a proposal from the Commission, take before 1 January 1991 a decision on the incorporation into meat products of starch or proteins of animal or vegetable origin and the maximum permissible percentages from a  technological viewpoint.   Until such decision is taken, national rules restricting the use of the abovementioned substances and the bilateral arrangements in force on the date of notification of this Directive and concerning such incorporation shall remain applicable in  compliance with the general provisions of the Treaty and, in particular, in so far as they apply without any distinction being made between national products and imported products and without prejudice to any initiatives to be embarked upon under a  Community procedure with a view to their approximation.   Member States which authorize the said incorporation shall ensure that details of such incorporation and the incorporated products referred to in the firssubparagraph are entered on the label in accordance with Directive 79/112/EEC.   Member States which authorize the incorporation of proteins of vegetable origin as a meat substitute shall ensure that the label does not contain any indication that could cause the consumer to think that the meat product has been produced either from  or with meat.   Article 161. This Directive shall not affect the channels of appeal open under the current legislation in Member States against the decisions of the competent authorities provided for in this Directive.   2. Each Member State shall grant consignors of meat products, the movement of which is prohibited pursuant to Article 12 (4), the right to obtain the opinion of an expert. Each Member State shall ensure that, before the competent authorities take any  other measures such as destroying the meat products, the experts have an opportunity of determining whether the conditions of Article 1 2 (4) have been fulfilled.   The expert must be national of a Member State other than the exporting country or country of destination.   Acting on a proposal from the Member States, the Commission shall draw up a panel list of the experts who may be instructed to give such opinions. After consulting the Member States, it shall lay down general rules which are to be applied, in particular  as regards the procedure for giving these opinions.   Article 171. Pending the implementation of Community provisions concerning imports of meat products from third countries, Member States shall apply to such imports provisions which shall not be more favourable than those governing intra-Community trade.  In order to do this, such imports must come from establishments that meet at least the requirements of Annexes A and B.   To ensure uniform application of these provisions, inspections shall be carried out on the spot by veterinary experts of the Member States and the Commission.   Member States' experts undertaking these inspections shall be designated by the Commission on a proposal from the Member States.   These inspections shall be carried out on behalf of the Community, which shall bear the expenditure incurred.   However, Member States shall be entitled to continue to make inspections under national arrangements of any third country meat product plants which have not been inspected under the Community procedure.   A list of establishments meeting the conditions referred to in Annexes A and B shall be drawn up under the Article 18 procedure.   2. The health certificate which accompanies the meat product on import, and the form and nature of the health mark which this product or preparation shall bear, shall correspond to a model to be determined in accordance with the Article 18 procedure.'  Article 2 Annexes A and B to Directive 77/99/EEC are replaced by Annexes A, B and C to this Directive.   Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1990 and, as concerns compliance with the provisions relating to meat and preparations  referred to by Directive 88/657/EEC, they shall do so not later than 1 January 1992. They shall forthwith inform the Commission thereof.   However, the Hellenic Republic shall have an additional period expiring on 31 December 1992 within which to comply with the exception provided for in Article 3 (1) (9) of Directive 77/99/EEC.   Article 4 This Directive is addressed to the Member States.    Done at Brussels, 14 December 1988.   For the Council  The President  Y. POTTAKIS     (1) OJ No C 349, 31. 12. 1985, p. 43.  (2) OJ No C 46, 23. 2. 1987, p. 127.  (3) OJ No C 189, 28. 7. 1986, p. 35.  (4) OJ No L 59, 5. 3. 1983, p. 10.  (5) OJ No L 26, 31. 1. 1977, p. 85.  (6) OJ No L 357,19. 12. 1987, p. 1.  (7) OJ No L 33, 8. 2. 1979, p. 1.  (8) OJ No L 144, 29. 5. 1986, p. 38.(9) OJ No L 47, 21. 2. 1980, p. 4.  (10) OJ No L 279, 2. 10. 1987, p. 27.(11) OJ No L 47, 21. 2. 1980, p. 4.(12) See page 3 of this Official Journal.   ANNEX A   CHAPTER I GENERAL CONDITIONS FOR APPROVAL OF ESTABLISHMENTS   Without prejudice to the special conditions laid down in Annex B, establishments shall have at least:   1. in rooms where fresh meat or meat products are produced, worked on or stored and where meat preparations are stored:   (a) waterproof flooring which is easy to clean and disinfect, rotproof and laid in such a way to facilitate the draining of water; the water must be channelled towards drains fitted with gratings and traps to prevent odours.   However, establishments shall have:   - in those rooms in which chilled or refrigerated meat, meat preparations, or meat products are stored, waterproof flooring which is easy to clean and disinfect, rotproof and laid in such a way as to facilitate the draining of water,   - in those rooms in which deep-frozen meat, meat products or meat preparations are stored, waterproof and rotproof flooring;   (b) smooth, durable, impermeable walls, with a light-coloured, washable coating up to a height of at least two metres and up to at least storage height in chilling or refrigeration rooms and in stores. Wall to floor junctions must be rounded or  similarly finished except in the rooms referred to in Annex B, Chapter I, 1 (a) and (b);   (c) doors in material that does not deteriorate and, if of wood, with a smooth and impermeable covering on both sides;   (d) insulation materials which are rotproof and odourless;   (e) adequate ventilation and if necessary good extraction of steam and water-vapour;   (f) adequate natural or artificial lighthing which does not distort colours:   (g) a clean and easily cleaned ceiling or, failing that, a roof covering with an interior surface which fulfils these conditions;   2. as near as possible to the work stations:   (a) a sufficient number of facilities for cleaning and disinfecting hands and for cleaning tools with hot water. Taps must not be hand or arm operable. For washing hands, these facilities must have hot and cold running water or water premixed to a  suitable temperature, cleaning and disinfecting products and hand towels which can be used once only;   (b) facilities for disinfecting tools, with water supplied at not less than 82 oC.   Facilities for cleaning and disinfecting tools are not required when such cleaning is effected by a machine situated in a room separate from the work stations;   3. appropriate arrangements for protection against pests such as insects and rodents;   4. (a) instruments and working equipment such as cutting tables, tables with detachable cutting surfaces, containers, conveyor belts and saws, made of corrosion-resistant material, not liable to taint meat, meat products and meat preparations and easy  to clean and disinfect. The use of wood is forbidden;   (b) corrosion-resistant fittings and equipment meeting hygiene requirements for:   - handling meat, meat products and meat preparations,   - setting down meat, meat products or meat preparation containers in such a way that the meat, the meat products, the meat preparations and the containers do not come into contact with the floo(c) facilities for the hygienic handling and protection of  meat or meat products and meat preparations during loading and unloading;   (d) special watertight, corrosion-resistant containers, with lids and fasteners to prevent unauthorized persons from removing things from them, in which to put meat, meat products or meat preparations not intended for human consumption, or a lockable  room for such meat or meat products or meat preparations if the quantities are large enough to necessitate this or if they are not removed or destroyed at the end of each working day; where such meat, meat products or products referred to by Directive  88/657/EEC are removed through conduits, these should be so constructed and instalied as to avoid any risk of contamination of fresh meat, meat products or meat preparations;   5. a refrigeration plant to keep the internal temperature of the meat, or meat products or products referred to by Directive 88/657/EEC at the levels required by Directives 64/433/EEC and 71/118/EEC and by this Directive.   This plant shall include a system for draining off condensed water without any possibility, of contamination of the meat, meat products or meat preparations;   6. plant for the exclusive supply under pressure of a sufficient quantity of potable water within the meaning of Directive 80/778/EEC; however, as an exception, authorization can be given for the plant supplying non-potable water to be used for steam  production, fire-fighting and the cooling of reftigeration equipment, providing that the pipes installed for this purpose preclude the use of this water for other purposes and present no risk of contamination of meat, meat products and meat  preparations. Non-potable water pipes shall be clearly distinguished from those used for potable water;   7. plant providing an adequate supply of hot potable water within the meaning of Directive 80/778/EEC;   8. a waste water disposal system which meets hygiene requirements;   9. an adequately equipped lockable room for the exclusive use of the competent authority or, in the case of storage premises located apart from the establishment approved for the production of meat products or meat preparations, a properly equipped area  for its use;   10. facilities enabling the inspection operations provided for in the Directive to be carried out efficiently at any time;   11. an appropriate number of changing rooms with smooth, waterproof washable walls and floors, wash basins, showers and flush lavatories which fulfil all conditions of hygiene. Lavatories must not open directly on to the work rooms. The wash basins must  have hot and cold running water or water premixed to a suitable temperature, materials for cleaning and disinfecting the hands and hand towels for use once only. The wash basin taps must not be hand or arm operable. There must be a sufficient number of  such wash basins near the lavatories;   12. a place and adequate facilities for cleaning and disinfecting means of transport. This place and these facilities are not, however, compulsory if provisions exist requiring that means of transport be cleaned and disinfected at officially authorized  facilities.   CHAPTER II HYGIENE OF STAFF, CLEANLINESS OF PREMISES, EUIPMENT AND INSTRUMENTS IN ESTABLISHMENTS   13. Absolute cleanliness shall be required of staff, premises and equipment:   (a) staff shall in particular wear clean working clothes and headgear and, where necessary, a neck shield. Staff engaged in working on or handling meat, meat products or meat preparations shall wash and disinfect their hands several times during the  worhave been in contact with infected meat shall immediately wash their hands and arms carefully with hot water and then disinfect them. Smoking is forbidden in work rooms and store rooms;   (b) no animal may enter the establishments. Rodents, insects and other vermin in the establishments shall be systematically destroyed;   (c) equipment and implements used for working on fresh meat, meat products and meat preparations shall be kept clean and in a good state of repair. They shall be carefully cleaned and disinfected several times during the working day, at the end of the  days work and before being re-used when they have been soiled.   Continuous production machines shall at least be cleaned when work is finished or in the event of doubt about their cleanliness;   14. work-rooms and working instruments and equipment shall not be used for purposes other than work on fresh meat, meat products and meat preparations.   However, they may be used for the preparation of other foodstuffs either simultaneously or at different times after authorization by the competent authority, provided that all appropriate measures are taken to prevent contamination of the products  covered by this Directive or adverse changes in them;   15. fresh meat, meat products and meat preparations, their ingredients and containers shall not:   - come into direct contact with the ground,   - be left or handled in conditions which might contaminate or damage them.   Care shall be taken to ensure that there is no contact between raw materials and finished products;   l6. potable water shall be used for all purposes;   17. the spreading of sawdust or any other similar substance on the floor of the workrooms and storage rooms is prohibited;   18. detergents, disinfectants and similar substances shall be used in such a way that equipment, working instruments, fresh meat, meat products and the products referred to by Directive 88/657/EEC are not adversely affected. Their use shall be followed  by thorough rinsing of such equipment and working instruments with potable water. Products for maintenance and cleaning shall be kept in the place provided for in Annex B, Chapter I (1) (g);   19. persons likely to contaminate fresh meat, meat products or the products referred to by Directive 88/657/EEC shall be prohibited from working on them and handling them;   20. any person employed to work with or handle fresh meat or meat products shall produce a medical certificate attesting that there is no impediment to such employment. The medical certificate shall be renewed every year, unless some other staff medical  check-up scheme offering equivalent guarantees is recognized in accordance with the procedure laid down in Article 18:   21. by way of derogation from point 4 (a) of this Annex, the use of wood is permitted in rooms in which meat products are smoked, cured, matured, pickled, stored or dispatched, when essential for technological reasons, provided there is no risk of the  products being contaminated. Wooden pallets may be brought into the said rooms solely for transporting packaged meat products and for no other purpose;   22. the temperatures in rooms or parts of rooms where work on fresh meat, meat products and meat preparations is carried out shall ensure hygienic production; if necessary, such rooms or parts of rooms shall be provided with air-conditioning facilities.    When in use, rooms for cutting and curing shall be kept at a temperature not exceeding 12 oC.   Rooms for slicing, cutting and wrapping meat products intended for sale in prepackaged form shall be kept at a temperature not exceeding 12 oC.   The temperature laid down in the third subparagraph may be departed from, wirh the agreement of the competent aurhority, if it considers it possible to do so for technical preparation reasons, particularly in the case of slicing rooms in order to  CHAPTER III REQUIREMENTS FOR FRESH MEAT TO BE USED FOR THE MANUFACTURE OF MEAT PRODUCTS   23. Fresh meat which comes from a slaughterhouse, cutting establishment, cold store:or other processing establishment in the same country as the establishment concerned shall be transported to it under satisfactory hygiene conditions in accordance with  the provisions of the Directive referred to in Article 2 except those on sealing;   24. not later than 31 December 1992, and without prejudice to point 26, meat which does not comply with the conditions set out in Article 2 may not be heid in approved establishments. Until that date, meat which does not comply with the conditions set  out in Article 2 (c) may be held in approved establishments only if stored in separate places; it shall be used in other places or at other times than meat which does not comply with these conditions;   The competent authority shall at all times have free access to cold stores and to all work rooms in order to verify strict compliance with these provisions.   Packaged meat and packaged fresh meat shall be kept in separate cold storerooms;   25. as soon as it arrives at the establishment and until it is used, fresh meat intended for processing shall be kept in accordance with the provisions of the Directives referred to in Article 2;   26. by way of derogat!on from point 24 and Article 2, the competent authority may authorize, in the establishments, the presence of meat from animals other than those indicated in the directives referred to in Article 2 for the manufacture of meat  products, provided it is obtained in accordance with national rules and is transported, treated and stored in accordance with the provisions of this Directive. Trade in these products shall be subject to the requirements laid down in Article 3 (1) (3)  (a) (iv); products produced in such authorized establishments and destined for intra-Community trade may be prepared only under official veterinary supervision and must be protected from any contamination or re-contamination.   CHAPTER IV SUPERVISION OF PRODUCTION   27. Establishments shall be subject to supervision by the competent authority, which shall be given due notice before the work on meat products intended for intra-Community trade is carried out;   28. supervision by the competent authority shall include the following:   - verification of the cleanliness of the rooms, plant and instruments and of staff hygiene, in accordance with Chapter II,   - inspection of the entry and exit register for fresh meat, meat products and meat preparations,   - sanitary inspection of fresh meat and meat preparations intended for the manufacture of products intended for intra-Community trade and, in the case referred to in Article 3 (3) (b), of meat preparations,   - inspection of the effectiveness of the treatment of meat products,   - inspection of meat products when they leave the establishment,   - taking of any samples required for laboratory tests,   - preparation and issue of the health certificate provided forin point 40,   - any other supervision measures  considered necesarry by the competent authority to ensure compliance with this Directive.   The results of the various checks carried out, in accordance with Article I I and Annex B, Chapters II and III (2) (b) and Article 12, by the producer must be kept for two years so that they can be shown on receipt of any request from the competent  authority.   29. the competent authority shall check whether a meat product has been made from meat in which other foodstuffs, additives or condiments have been incorporated, by submitting to an appropriate inspection and assessing whether it complies with the  production criteria laid down by the producer and especially whether the composition of the product truly corresponds to what is stated on the label;   30. the competent authority must in particular ensure that intra-Community trade in meat products and in products referred to by Directive 88/657/EEC made from the fresh meat referred to in Article 5 (c) to (h) of Directive 64/433/EEC cannot take place.    CHAPTER V WRAPPING AND PAGKAGING OF MEAT PRODUCTS   31. Wrapping and packaging shall take place under satisfactory hygiene conditions in rooms provided for that purpose;   32. wrapping and packaging shall comply with all the rules of hygiene, and in particular:   - not be such as to affect adversely the organoleptic characteristics of the meat products,   - not be capable of transmitting to the meat products substances harmful to human health,   - be strong enough to protect the meat products effectively;   33. wrappings may not be re-used for meat products, with the exception of certain special types of earthenware and glass containers which may be re-used after effective cleaning and disinfecting;   34. manufacture of meat products and wrapping and packaging operations may take place in the same room subject to the following conditions:   (a) the room shall be sufficiently large and so equipped that the hygiene of the operations is assured;   (b) the packaging and wrapping shall be enclosed in a sealed protective cover immediately after manufacture; this cover shall be protected from damage during transport to the establishment and stored under hygienic conditions in a seperate room in the  establishment;   (c) the rooms for storing the packaging material shall be free from dust and vermin and have no atmospheric connection with rooms containing substances which might contaminate fresh meat, the products referred to by Directive 88/657/EEC or meat  products. Packaging shall not be placed directly on the floor;   (d) packaging shall be assembled under hygienic conditions before being brought into the room. A derogation from this requirement may be granted in the case of the automatic assembly of packaging, provided there is no risk of contamination of meat  products;   (e) packaging shall be brought to the room under hygienic conditions and used without delay. It may not be handled by staff handling unwrapped fresh meat or meat products;   (f) immediately after packaging, the meat products shall be placed in the storage rooms provided for the purpose;   35. the producer shall ensure for inspection purposes that in addition to the information required by Directive 79/112/EEC the following information is visibly and legibly displayed on the wrapping or, under the conditions set out in point 36 on the  label of meat products:   - where it is not clear from the sales description, the species from which the meat was obtained, and, in the case of a mixture, the percentage of each species,   - information allowing the consignment to be identified,   - for packaging not intended for the final consumer, the date of preparation,   - the list of condiments and of any other foodstuffs.   CHAPTER VI MARKING AND LABELLING   36. Meat products shall carry a health mark. Marking must be carried out under the responsibility of the competent authority, during or immediately after manufacture, in an easily visible place. The mark shall be legible, indelible and its characters  easily distinguishable. The mark may be applied to the product or to the  wrapping, if the meat product is individually wrapped, or to a label affixed to this wrapping in accordance with point 39 (b). However, where a meat product is individually wrapped and packaged, it will suffice for the health mark to be applied to the  packaging;   37. where meat products marked in accordance with point 36 are subsequently placed in a second packaging, the mark shall also be applied to that second packaging;   38. by way of derogation from points 36 and 37, the health marking of meat products in palletized consignments intended for further processing or wrapping in an approved establishment is not necessary, provided that:   - the said consignments containing the meat products bear the health mark in accordance with point 39 (a) on the external surface,   - the dispatch establishment maintains a separate record of the guantities,type and destination of meat products dispatched in accordance with this paragraph,   - the recipient establishment maintains a separate record of the quantities, type and origin of meat products received in accordance with this paragraph,   - the health marking is destroyed only when the consignment is opened under the responsibility of the competent authority,   - the destination and intended use of meat products are clearly indicated on the external surface of the large packaging except when this is transparent.   However where a consignment of packages is contained within a transparent outer wrapping, it shall not be necessary to health mark the outer wrapping as long as the health mark on the packages is clearly visible through the outer wrapping;   39. (a) the health mark shall give the following particulars within an oval surround:   (i) either:   - above:   the initial letter or letters of the consigning country in capitals, i.e. B/D/DK/EL/ESP/F/IRL/I/L/NL/P/UK, followed by the approval number of the establishment,   - below:   one of the following sets of initials: CEE - EEC - EEG - EOK - EWG - EOEF;   (ii) or:   - on the upper part, the name of the consigning country capitals  - in the centre, the veterinary approval number of the establishment,   - on the lower part, one of the following sets of initials: CEE, EEC, EEG, EOK, EWG, EOEF;   (b) the health mark may be applied to the product, wrapping or packaging by an ink stamp or by branding, or it may be printed on or applied to a label. If it is applied on the packaging, the mark must be destroyed when the package is opened.  Non-destruction of this mark may be tolerated only when the packaging is destroyed by being opened. In the case of hermetically sealed containers, the mark must be indelibly marked either on the lid or on the can;   (c) the health mark may also consist of an irremovable plate of resistant material complying with all the hygiene requirements and bearing the information specified in paragraph (a).   CHAPTER VII HEALTH CERTIFICATE   40. The original copy of the health certificate which must accompany meat products, except the products referred to in Article 3 (1) (9), second sentence, during their transportation to the country of destination must be issued by the competent  authority at the time the meat products are loaded.   The health certificate must correspond in form and content to the model in Annex C; it must be made out at least in the official language (5) of the country of destination and must contain the particulars laid down. It must consist of a single sheet of  paper. CHAPTER VIII STORAGE AND TRANSPORT   41. Meat products shall be stored in the rooms provided for in Annex B, Chapter I (1)  (a), or in a cold store approved in accordance with Directive 6433/EEC.   Meat products which can be kept at ambient temperatures may be stored in stores situated outside an establishment approved for the production of meat products provided such stores are approved by the competent authorities on conditions equivalent to  those provided for by this Directive;   42. meat products for which certain storage temperatures are indicated in accordance with Article 4 shall be maintained at those temperatures;   43. meat products shall be transported in such a way that they are protected during transportation from anything which may contaminate them or be detrimental to them. For this purpose account should be taken of the length of the iourney, the means of  transport employed and the weather conditions;   44.meat products, if the product so requires, shall be transported in vehicles equipped to ensure that they can be transported in the refrigerated state and in particular that the temperatures indicated in accordance with Article 4 are not exceeded.   ANNEX B   CHAPTER I SPECIAL CONDITIONS FOR APPROVAL OF ESTABLISHMENTS MANUFACTURING MEAT PRODUCTS   1. Beyond the general requirements laid down in Annex A, Chapter I, establishments manufacturing and wrapping meat products shall have at least:   (a) until not later than 31 December 1992, suitable rooms large enough for the separate storage:   (i) under refrigeration:   - of fresh meat within the meaning of Article 2 (b)  (ii) and meat preparations within the meaning of Article 2 (c),   - of meat and meat preparations other than those referred to in the first indent;   (ii) at ambient temperature or, where appropriate, under refrigeration:   - of meat products fulfilling the requirements set out in this Directive,   - of other products prepared wholly or partly from meat;   (b) as from 1 January 1993 at the latest, suitable rooms large enough for the separate storage:   (i) under refrigeration, of fresh meat and meat preparations;   (ii) at ambient temperature or, where appropriate, under refrigeration:   - of meat products meeting the requirements set out in this Directive,   - of other products prepared wholly or partly from fresh meat;   (c) one or more suitable rooms sufficiently large for manufacture and wrapping;   (d) a lockable room for the storage of certain ingredients such as additives;   (e) a room for packaging, unless the conditions laid down for packaging in Annex A, Chapter V, point 34, are fulfilled, and for dispatch;   (f) a room for the storage of wrapping and packaging materials;   (g) a room for cleaning movable equipment such as hooks and containers, and a room or a cupboard for the storage of cleaning and maintenance tools and products.   2. Depending on the type of product involved, the establishment shall have:   (a) a room or - if there is no danger of contamination - an area where packaging is removed:   (b) a room or - if there is no danger of contamination - an area for thawing out fresh meat:   (c) a cutting room;   (d) a room for filling containers prior to heat treatment;   (e) a room:   - for cooking (equipment for heat treatment shall be fitted with a recording thermometer or telethermometer),   - for retorting (the retorts shall be fitted wirh a recording thermometer or telethermometer, and a direct-reading control thermometer; retorts shali also be equipped with a manometer);   (f) a room for rendering down fats;   (g) a room or special equipment for smoking;   (h) a room for drying and maturing;   (i) a room for desalting, soaking or otherwise treating narural guts;   (j) a room for the prior cleaning of foodstuffs which are necessary for th(k) a curingroom, if necessary with air-conditioning facilities enabling the temperature stipulated in point 22 of Chapter II of Annex A to be maintained;   (1) room, if necessary, for the prior cleaning of meat products intended to be sliced or cut and wrapped;   (m) a room, if necessary with air-conditioning facilities, for slicing or cutting and for wrapping meat products intended for sale in pre-packed form;   (n) a device for conveying empty cans hygienically to the work room;   (o) an apparatus enabling containers to be thoroughly cleaned immediately before filling;   (p) an apparatus for washing containers in potable water which is hot enough to remove grease after they have been hermetically sealed and before retorting;   (q) a suitable room or area for cooling and drying containers after heat treatment;   (r) facilities for the incubation of samples taken from meat products packed in hermeticaliy sealed containers;   (s) adequate facilities for checking whether containers are hermetically sealed and undamaged.   However, provided that the equipment used can have no deleterious effect on the fresh meat or meat products the same room may be used for the operations to be carried out in the separate rooms referred to in (e) and (f).   The operations carried outin the rooms referred to in (c), (d), (e), (g) and (m) may be carried out in the room referred to in paragraph 1 (c) provided that the installations constitute a single cycle of a continuous production line without interruption  of work and guarantee that the other requirements of this Directive are complied with and that there is no risk of contamination of the fresh meat or meat products.   CHAPTER II SPECIFIC REQUIREMENTS CONCERNING HERMETICALLY-SEALED CONTAINERS   In addition to the general provisions, establishments which manufacture meat products in hermetically-sealed containers shall fulfil the following requirements:   l. the competent authority shall ensure, for meat products in hermetically-sealed containers, that:   (a) the operator or proprietor of the estabiishment or his representative checks, by sampling,that:   - a process is applied to meat products intended for storing at ambient temperature resulting in an Fc value equal to or exceeding 3,00 or, in Member States in which this value is not customarily employed, a check on the treatment by means of a  seven-day incubation test at 37 oC or a 10-test at 35 oC,   - a proper heat treatment procedure is applied, determined on the basis of representative criteria such as heating time, temperature, movement during heating, filling, etc.,   - empty containers meet production standards,   - checks on the daily output are carried out at intervals determined in advance, to ensure the efficacy of the sealing,   - the necessary checks are carried out using in particular control markers to ensure that the containers have in fact undergone adequate heat treatment,   - the necessary checks are carried out to ensure that the cooling water contains a residual level of chlorine after use. Member States may, however, grant a derogation from this requirement if the water fulfils the requirements of Directive 80/778/EEC,    - incubation tests are carried out on meat products, in a hermetically-sealed container, which have undergone heat treatment in accordance with the first indent,   - a distinguishing mark is put on the containers allowing meat products produced at the same time and under the same conditions to be identified;   (b) products in hermetically-sealed containers are removed from the heating equipment at a sufficiently high temperature to ensure rapid evaporation of humidity and are not touched by hand until completely dry;   (c) cans in which gas appears to be present undergo a further examination;   (d) the thermometers of hearing equipment are checked against calibrated thermometers;   2. containers shall be:   - rejected if damaged or badly made,   - thoroughly cleaned immediately before filling, by means of the cleaning apparatus referred to in Chapter I, point 2 (o); the use of static water is not authorized,   - if necessary, drained for a sufficiently long time after cleaning and before filling,   - if necessary, washed in potable water, sufficiently hot to remove grease if appropriate, after they have been hermetically-sealed and before retorting, by means of the apparatus referred to in Chapter I, point 2 (p),   - cooled, after heating, in water meeting the requirements in point 1 (a), sixth indent,   - handled in such a way before and after heat treatment that any type of damage or contamination is avoided.   3. Member States may authorize the addition of certain substances to the water used in retorts in order to prevent corrosion of cans and to soften and disinfect the water. A list of these substances will be drawn up in accordance with the procedure laid  down in Article 18.   4. Member States may allow the use of recirculated water for cooling heat-processed containers. Such water must be filtered and have either been treated with chlorine or undergone some other treatment approved in accordance with the procedure laid down  in Article 18. The purpose of such treatment is to make the recirculated water comply with the standards laid down in Annex I (E) to Directive 80/778/EEC so that it cannot contaminate the products and does not constitute a hazard to human health.   The recirculated water shall circulate in closed circuit so that it can not be used for other purposes;   5.where there is no risk of contamination, the water used for cooling containers and water from retorts may be used at the end of a working period for cleaning floors.   CHAPTER III SPECIAL REQUIREMENTS FOR THE PRODUCTION OF PREPARED MEALS   Beyond the general requirements of Annex A, Chapter I, and depending on the type of production concerned:   1. (a) if the production of prepared meals do not take place in the room laid down for that purpose in Chapter I (1) (c), the establishment shall posses a separate room for the production of prepared meals;   (b) the production of prepared meals shall take place under conditions of temperature control;   2. (a) the operator or proprietor of the establishment or his representative shall conduct a regular check on the general hygiene of conditions of production in his establishment, in particular by microbiologicai controls in accordance with the fourth  subparagraph.   These controls shall cover utensils, fittings and machiner at all stages of production and, according to the type of production concerned, products.   He shall be in a position, upon request from the official service, to inform the competent authority or the Commission's veterinary experts of the nature, frequency and results of the controls conducted to this end, together with the name of the  investigating laboratory if need be.   The nature of these controls, their frequency, as well as the sampling methods and the methods for bacteriological examination will be stipulated in a code of good hygiene practices to be drawn up under the Article 18 procedure;   (b) the competent authority shall regularly analyse the results of the controls provided for in (a). It may, on the basis of this analysis, conduct further microbiological examinations at all stages of production or on the products.   The results of these analyses shall be written up in a report, the conclusions and recommendations of which shall be notified to the operator, who shall see to the rectification of shortcomings noted with a view to improving hygiene;   3. in addition, prepared meals which have been cooked and are intended for direct sale to consumers shall:   - be packaged immediately before or after cooking,   - after cooking and packaging operations, be cooled rapidly in an insulated chamber which is satisfactory from the hygiene point of view,   - be cooled to an internal temperature of + 10 oC within a period of not more than two hours after the end of the cooking,   - where appropriate, be frozen or quick frozen immediately after they have been cooled;   4. labelling of prepared meals shall be carried out in accordance with Directive 79/118/EEC. The list of ingredients shall, for the purposes of this Directive, include a mention of the animal species included;   5. prepared meals shall bear the date of manufacture in very clear terms on one of the outer surfaces of the wrapp!ng in addition to the particulars already specified.   ANNEX C   HEALTH CERTIFICATE FOR MEAT PRODUCTS (;) INTENDED FOR A MEMBER STATE OF THE EEC   NO ($) (=)  Exporting country:   Ministry:   Department concerned:   Reference ($):   I. ldentification of meat products  products manufactured with meat from:   (Animal species)  Nature of products (%):   Nature of packaging:   Number of individual items or of packages:   Storage and transport temperature (&  )  Storage life (&  ):   Net weight:   II. Origin of meat products  Address(es) and veterinary approval number(s) of approved processing establishment(s) (=):   If necessary:   Address(es) and veterinary approval number(s) of approved refrigeration store(s) (=):   III. Destination of meat products  The meat products are to be sent  from:   (Place of dispatch)  to:   (Country of destination)  by the following means of transport (() (=):   Name and address of consignor:   Name and address of consignee:   (;) Within the meaning of Article 2 of Directive 77/9/EEC.   ($) Optional.   (=) In cases of unloading and reloading in an establishment or an approved cold store the competent authority must complete the certificate (Registration number, date, place, stamp and signature).   (%) Mention any ionizing radiation for medical reasons.   (&  ) To be completed where an indication is given in accordance with Article 4 of Directive 77/99/EEC.   (() Indicate the number or registration number (railway wagons and lorries), the flight number (aircraft) or the name (ship).   IV. Health attestation  I. the undersigned, certify that:   (a) the meat products described above were manufactured from fresh meat or meat products under conditions that comply with the requirements of Directive 77/99/EEC:   (b) the meat products have/have not (;) been treated in accordance with Annex B, Chapter I (a), first indent of Directive 77/99/EEC;   (c) the said meat products, their wrappings or packaging, bear a mark proving that they have all come from approved establishments (;);   (d) the transport vehicles and equipment and the way in which the consignment was loaded comply with the hygiene requirements laid down in Directive 77/99/EEC;   (e) the fresh pigmeat used has/has not been (;) subjected to a trichinae detection test.   Done at on(place) (


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31985L0324

Council Directive 85/324/EEC of 12 June 1985 amending Directive 71/118/EEC on health problems affecting intra- Community trade in fresh poultrymeat

Official Journal L 168 , 28/06/1985 P. 0045 - 0046 Finnish special edition: Chapter 3 Volume 18 P. 0206  Spanish special edition: Chapter 03 Volume 35 P. 0178  Swedish special edition: Chapter 3 Volume 18 P. 0206  Portuguese special edition Chapter 03 Volume 35 P. 0178

*****COUNCIL  DIRECTIVE  of 12 June 1985  amending Directive 71/118/EEC on health problems affecting intra-Community trade in fresh poultrymeat  (85/324/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 Council Directive 71/118/EEC (4), as last amended by Directive 84/642/EEC (5), lays down the hygiene conditions under which fresh poultrymeat must be produced in slaughterhouses and cutting plants; whereas that Directive provided for health inspections to be carried out; whereas microbiological analyses covering , inter alia, equipment, utensils and carcases constitute a means for achieving an objective assessment of the standard of hygiene;  Whereas microbiological control provides the health inspection service with useful information and so constitutes an effective means of checking and improving the standard of hygiene in establishments;  Whereas the execution of microbiological control in slaughterhouses and cutting plants must be based on the use of harmonized microbiological methods in order to obtain reliable results and to this end a code of good practice should be worked out,  HAS ADOPTED THIS DIRECTIVE:  Article 1  The following section is hereby inserted in Chapter II of Annex I to Directive 71/118/EEC:  '4a (a) The operator or proprietor of the establishment or his representative must conduct a regular check on the general hygiene of conditions of production in his establishment, including by microbiological controls in accordance with the fourth subparagraph.  These controls should cover utensils, fittings and machinery at all stages of production and, if necessary, products.  He must be in a position, upon request from the official service, to inform the official veterinarian or the Commission's veterinary experts of the nature, frequency and results of the controls conducted to this end, together with the name of the investigating laboratory if need be.  The nature of these controls, their frequency, as well as the sampling methods and the methods for bacteriological examination will be stipulated in a code of good hygiene practices to be drawn up under the Article 12a procedure, at least six months before the date referred to in the first subparagraph of Article 2 of Directive 85/324/EEC (1).  (b) The official veterinarian will regularly analyze the results of the controls provided for in (a). He may, on the basis of this analysis, conduct further microbiological examinations at all stages of production or on the products.  The results of these analyses will be written up in a report, the conclusions and recommendations of which will be notified to the operator, who will see to the rectification of shortcomings noted with a view to improving hygiene.  (1) OJ No L 168, 28. 6. 1985, p. 45.'  Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive at the latest on the date which will be fixed by the Council when the review of certain national derogations for the refrigeration of carcases, as provided for in Article 16b of Directive 71/118/EEC, takes place.  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 252, 2. 10. 1981, p. 11.  (2) OJ No C 267, 11. 10. 1982, p. 59.  (3) OJ No C 112, 3. 5. 1982, p. 7.  (4) OJ No L 55, 8. 3. 1971, p. 23.  (5) OJ No L 339, 27. 12. 1984, p. 26.


Avis juridique important

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31997L0021

Commission Directive 97/21/EC of 18 April 1997 adapting to technical progress Council Directive 80/1269/EEC on the approximation of the laws of the Member States relating to the engine power of motor vehicles (Text with EEA relevance)

Official Journal L 125 , 16/05/1997 P. 0031 - 0040

COMMISSION DIRECTIVE 97/21/EC of 18 April 1997 adapting to technical progress Council Directive 80/1269/EEC on the approximation of the laws of the Member States relating to the engine power of motor vehicles (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 80/1269/EEC of 16 December 1980 on the approximation of the laws of the Member States relating to the engine power of motor vehicles (1), as last amended by Commission Directive 89/491/EEC (2), and in particular Article 3 thereof,Whereas Directive 80/1269/EEC is one of the separate directives in the EC type-approval procedure established by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (3), as last amended by Directive 96/79/EC of the European Parliament and of the Council (4); whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to Directive 80/1269/EEC;Whereas, in particular, pursuant to Article 3 (4) and Article 4 (3) of Directive 70/156/EEC it is necessary that each separate Directive has attached to it an information document incorporating the relevant items of Annex I to Directive 70/156/EEC and also a type-approval certificate based on Annex VI to Directive 70/156/EEC in order that type-approval may be computerized;Whereas these amendments relate only to the administrative provisions contained in Directive 80/1269/EEC; whereas it is not necessary therefore to invalidate existing approvals pursuant to Directive 80/1269/EEC nor to prevent the registration, sale and entry into service of new vehicles covered by such approvals;Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC,HAS ADOPTED THIS DIRECTIVE:Article 1Directive 80/1269/EEC is hereby amended as follows:1. Article 1 is replaced by the following:'Article 1For the purposes of this Directive, "vehicle" means any motor vehicle intended for use on the road, with or without bodywork, having at least four wheels and a maximum design speed exceeding 25 km/h, with the exception of vehicles which run on rails and of agricultural and forestry tractors and all mobile machinery.`;2. in Article 2, 'Annexes I and II` is replaced by 'the relevant Annexes`;3. the Annexes are amended in accordance with the Annex to this Directive.Article 2With effect from 1 October 1997, Member States:- shall no longer grant EC type-approval pursuant to Article 4 (1) of Directive 70/156/EEC, and- may refuse national type-approval,for a new type of vehicle on grounds relating to the engine power if the engine power has not been determined in accordance with Directive 80/1269/EEC, as amended by this Directive.This Directive shall not invalidate any approval previously granted pursuant to Directive 80/1269/EEC nor prevent extensions of such approvals under the terms of the directive under which they were originally granted.Article 31. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 1997. They shall forthwith inform the Commission thereof.When 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.2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.Article 4This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 5This Directive is addressed to the Member States.Done at Brussels, 18 April 1997.For the CommissionMartin BANGEMANNMember of the Commission(1) OJ No L 375, 31. 12. 1980, p. 46.(2) OJ No L 238, 15. 8. 1989, p. 43.(3) OJ No L 42, 23. 2. 1970, p. 1.(4) OJ No L 18, 21. 1. 1997, p. 7.ANNEX AMENDMENTS TO THE ANNEXES TO DIRECTIVE 80/1269/EEC 1. A list of Annexes is inserted between the Articles and Annex I to read as follows:'LIST OF ANNEXESAnnex I: Determination of engine powerAppendix 1: Information documentAppendix 2: Type-approval certificateAnnex II: Test report`ANNEX I 2. Item 1 reads as follows:'1. ADMINISTRATIVE PROVISIONS FOR TYPE-APPROVAL1.1. Application for EC type-approval of a vehicle type1.1.1. The application for EC type-approval pursuant to Article 3 (4) of Directive 70/156/EEC of a vehicle type with regard to its engine power shall be submitted by the manufacturer.1.1.2. A model for the information document is given in Appendix 1.1.1.3. If the technical service responsible for the type-approval tests carries out the test itself, the following must be submitted:1.1.3.1. an engine representative of the type to be approved together with the auxiliary equipment specified in Table 1.1.2. Granting of EC type-approval of a vehicle type1.2.1. If the relevant requirements are satisfied, EC type-approval pursuant to Article 4 (3) and, if applicable, Article 4 (4) of Directive 70/156/EEC shall be granted.1.2.2. A model for the EC type-approval certificate is given in Appendix 2.1.2.3. An approval number in accordance with Annex VII to Directive 70/156/EEC shall be assigned to each type of vehicle approved. The same Member State shall not assign the same number to another type of vehicle.1.3. Modifications of the type and amendments to approvals1.3.1. In the case of modifications of the type approved pursuant to this Directive, the provisions of Article 5 of Directive 70/156/EEC shall apply.1.4. Conformity of production1.4.1. Measures to ensure the conformity of production shall be taken in accordance with the provisions laid down in Article 10 of Directive 70/156/EEC.`3. In item 2.1:'Annex I` is replaced by 'Annex II Section A`.4. In item 5.6:'Appendix I` is replaced by 'Annex II`.5. In item 6.4.2 the formula reads as follows:'ád = (fa)fm`.6. Item 7 reads as follows:'7. TEST REPORTThe test report shall contain the results and all the calculations required to determine the net power, as listed in Annex II. In order to draw up this document, the competent authority may use the report prepared by an approved or recognized laboratory pursuant to the provisions of this Directive.`7. Items 8 to 8.2.2 are deleted.8. Items 9 to 9.2 become items 8 to 8.2.9. Appendices 1 and 2 are replaced by the following Appendices 1 and 2:'Appendix 1INFORMATION DOCUMENT No. . . . pursuant to Annex I to Council Directive 70/156/EEC (1*) relating to EC type-approval of a vehicle with respect to the engine power >START OF GRAPHIC>(Directive 80/1269/EEC, as last amended by Directive . . ./. . ./EC)The following information, if applicable, must be supplied in triplicate and include a list of contents. Any drawings must be supplied in appropriate scale and in sufficient detail on size A4 or on a folder of A4 format. Photographs, if any, must show sufficient detail.If the systems, components or separate technical units have electronic controls, information concerning their performance must be supplied.0. GENERAL0.1. Make (trade name of manufacturer): .0.2. Type and general commercial description(s): .0.3. Means of identification of type, if marked on the vehicle (b): .0.3.1. Location of that marking: .0.4. Category of vehicle (c): .0.5. Name and address of manufacturer: .0.8. Address(es) of assembly plant(s): .1. GENERAL CONSTRUCTION CHARACTERISTICS OF THE VEHICLE1.1. Photographs and/or drawings of a representative vehicle: .1.8. Hand of drive: left/right (1): .3. POWER PLANT (q)3.1. Manufacturer: .3.1.1. Manufacturer's engine code (as marked on the engine, or other means of identification): .3.2.1.1. Working principle: positive ignition/compression ignition, four stroke/two stroke (1)3.2.1.2. Number and arrangement of cylinders: .3.2.1.2.1. Bore (r): . mm3.2.1.2.2. Stroke (r): . mm3.2.1.2.3. Firing order: .3.2.1.3. Engine capacity (s): . cm33.2.1.4. Volumetric compression ratio (2): .3.2.1.5. Drawings of combustion chamber, piston crown and, in the case of positive ignition engines, piston rings: .3.2.1.8. Maximum net power (t): . . . . . . . . . . kW at . min-1(manufacturer's declared value)3.2.1.9. Maximum permitted engine speed as prescribed by the manufacturer: . min-13.2.1.10. Maximum net torque (1): . . . . . . . . . . Nm at . min-1(manufacturer's declared value)3.2.2. Fuel: diesel oil/petrol/LPG/any other (1)3.2.2.1. RON, leaded: .3.2.2.2. RON, unleaded: .3.2.4. Fuel feed3.2.4.1. By carburettor(s): yes/no (1)3.2.4.1.1. Make(s): .3.2.4.1.2. Type(s): .3.2.4.1.3. Number fitted: .3.2.4.1.4. Adjustments (2)3.2.4.1.4.1. Jets: .3.2.4.1.4.2. Venturis: .3.2.4.1.4.3. Float-chamber level: .3.2.4.1.4.4. Mass of float: .3.2.4.1.4.5. Float needle: .Or the curve of fuel delivery plotted against the air flow and settings required to keep to the curve3.2.4.1.5. Cold start system: manual/automatic (1)3.2.4.1.5.1. Operating principle(s): .3.2.4.1.5.2. Operating limits/settings (1) (2): .3.2.4.2. By fuel injection (compression ignition only): yes/no (1)3.2.4.2.1. System description: .3.2.4.2.2. Working principle: direct injection/pre-chamber/swirl chamber (1)3.2.4.2.3. Injection pump3.2.4.2.3.1. Make(s): .3.2.4.2.3.2. Type(s): .3.2.4.2.3.3. Maximum fuel delivery (1) (2): . . . . . . . . . . mm3/stroke or cycle at a pump speed of: . . . . . . . . . . min-1 or, alternatively, a characteristic diagram: .3.2.4.2.3.4. Injection timing (2): .3.2.4.2.3.5. Injection advance curve (2): .3.2.4.2.3.6. Calibration procedure: test bench/engine (1)3.2.4.2.4. Governor3.2.4.2.4.1. Type: .3.2.4.2.4.2. Cut-off point3.2.4.2.4.2.1. Cut-off point under load: . min-13.2.4.2.4.2.2. Cut-off point without load: . min-13.2.4.2.5. Injection piping3.2.4.2.5.1. Length: . mm3.2.4.2.5.2. Internal diameter: . mm3.2.4.2.6. Injector(s)3.2.4.2.6.1. Make(s): .3.2.4.2.6.2. Type(s): .3.2.4.2.6.3. Opening pressure (2): . . . . . . . . . . kPa or characteristic diagram (2): .3.2.4.2.7. Cold start system3.2.4.2.7.1. Make(s): .3.2.4.2.7.2. Type(s): .3.2.4.2.7.3. Description: .3.2.4.2.9. Electronic control unit3.2.4.2.9.1. Make(s): .3.2.4.2.9.2. Description of the system: .3.2.4.3. By fuel injection (positive ignition only): yes/no (1)3.2.4.3.1. Working principle: intake manifold (single-/multi-point (1)) direct injection/other (specify) (1): .3.2.4.3.2. Make(s): .3.2.4.3.3. Type(s): .3.2.4.3.4. System description3.2.4.3.4.1. Type or number of the control unit: .3.2.4.3.4.2. Type of fuel regulator: .3.2.4.3.4.3. Type of air-flow sensor: .3.2.4.3.4.4. Type of fuel distributor: .3.2.4.3.4.5. Type of pressure regulator: .3.2.4.3.4.8. Type of throttle housing: .In the case of systems other than continuous injection give equivalent details.3.2.4.3.5. Injectors: opening pressure (2): . . . . . . . . . . kPa or characteristic diagram (2): .3.2.4.3.6. Injection timing: .3.2.4.3.7. Cold start system3.2.4.3.7.1. Operating principle(s): .3.2.4.3.7.2. Operating limits/settings (1) (2): .3.2.4.4. Feed pump3.2.4.4.1. Pressure (2): . . . . . . . . . . kPa or characteristic diagram (2): .3.2.5. Electrical system3.2.5.1. Rated voltage: . V, positive/negative ground (1)3.2.5.2. Generator3.2.5.2.1. Type: .3.2.5.2.2. Nominal output: . VA3.2.6. Ignition3.2.6.1. Make(s): .3.2.6.2. Type(s): .3.2.6.3. Working principle: .3.2.6.4. Ignition advance curve (2): .3.2.6.5. Static ignition timing (2) . degrees before TDC3.2.6.6. Contact-point gap (2): . mm3.2.6.7. Dwell-angle (2): . degrees3.2.7. Cooling system (liquid/air) (1)3.2.7.1. Nominal setting of the engine temperature control mechanism: .3.2.7.2. Liquid3.2.7.2.1. Nature of liquid: .3.2.7.2.2. Circulating pump(s): yes/no (1)3.2.7.2.3. Characteristics . , or3.2.7.2.3.1. Make(s): .3.2.7.2.3.2. Type(s): .3.2.7.2.4. Drive ratio(s): .3.2.7.2.5. Description of the fan and its drive mechanism: .3.2.7.3. Air3.2.7.3.1. Blower: yes/no (1)3.2.7.3.2. Characteristics: . , or3.2.7.3.2.1. Make(s): .3.2.7.3.2.2. Type(s): .3.2.7.3.3. Drive ratio(s): .3.2.8. Intake system3.2.8.1. Pressure charger: yes/no (1)3.2.8.1.1. Make(s): .3.2.8.1.2. Type(s): .3.2.8.1.3. Description of the system (e.g. maximum charge pressure: . . . . . . . . . . kPa, wastegate if applicable): .3.2.8.2. Intercooler: yes/no (1)3.2.8.4. Description and drawings of inlet pipes and their accessories (plenum chamber, heating device, additional air intakes, etc.): .3.2.8.4.1. Intake manifold description (include drawings and/or photos): .3.2.8.4.2. Air filter, drawings: . , or3.2.8.4.2.1. Make(s): .3.2.8.4.2.2. Type(s): .3.2.8.4.3. Intake silencer, drawings: . , or3.2.8.4.3.1. Make(s): .3.2.8.4.3.2. Type(s): .3.2.9. Exhaust system3.2.9.1. Description and/or drawing of the exhaust manifold: .3.2.9.2. Description and/or drawing of the exhaust system: .3.2.9.3. Maximum allowable exhaust back pressure at rated engine speed and at 100 % load: . kPa3.2.10. Minimum cross-sectional areas of inlet and outlet ports: .3.2.11. Valve timing or equivalent data3.2.11.1. Maximum lift of valves, angles of opening and closing, or timing details of alternative distribution systems, in relation to dead-centres: .3.2.11.2. Reference and/or setting ranges (1): .3.2.12. Measures taken against air pollution3.2.12.2. Additional anti-pollution devices (if any, and if not covered by another heading)3.2.12.2.1. Catalytic converter: yes/no (1)3.2.12.2.1.1. Number of catalytic converters and elements: .3.2.12.2.1.2. Dimensions, shape and volume of the catalytic converter(s): .3.2.12.2.2. Oxygen sensor: yes/no (1)3.2.12.2.3. Air injection: yes/no (1)3.2.12.2.4. Exhaust gas recirculation: yes/no (1)3.2.12.2.6. Particulate trap: yes/no (1)3.2.12.2.6.1. Dimensions, shape and capacity of the particulate trap: .3.2.12.2.7. Other systems (description and operation): .3.6. Temperatures permitted by the manufacturer3.6.1. Cooling system3.6.1.1. Liquid coolingMaximum temperature at outlet: . °C3.6.1.2. Air cooling3.6.1.2.1. Reference point: .3.6.1.2.2. Maximum temperature at reference point: . °C3.6.2. Maximum outlet temperature of the inlet intercooler: . °C3.6.3. Maximum exhaust temperature at the point in the exhaust pipe(s) adjacent to the outer flange(s) of the exhaust manifold: . °C3.6.4. Fuel temperatureminimum: . °Cmaximum: . °C3.6.5. Lubricant temperatureminimum: . °Cmaximum: . °C3.8. Lubrication system3.8.1. Description of the system3.8.1.1. Position of the lubricant reservoir: .3.8.1.2. Feed system (by pump/injection into intake/mixing with fuel, etc.) (1): .3.8.2. Lubricating pump3.8.2.1. Make(s): .3.8.2.2. Type(s): .3.8.3. Mixture with fuel3.8.3.1. Percentage: .3.8.4. Oil cooler: yes/no (1)3.8.4.1. Drawing(s): . , or3.8.4.1.1. Make(s): .3.8.4.1.2. Type(s): ..(Date, file)(1) Delete where not applicable.(2) If the means of identification of type contains characters not relevant to describe the vehicle, component or separate technical unit types covered by this type-approval certificate such characters shall be represented in the documentation by the symbol: '?' (e.g. ABC??123??).>END OF GRAPHIC>Addendum to Appendix 1>START OF GRAPHIC>1. Other auxiliary equipment driven by the engine (as per item 5.1.2 of Annex I) (list and brief description if necessary): .2. Additional information on test conditions (for positive ignition engines only)2.1. Spark plugs2.1.1. Make: .2.1.2. Type: .2.1.3. Spark-gap setting: .2.2. Ignition coil2.2.1. Make: .2.2.2. Type: .2.3. Ignition condenser2.3.1. Make: .2.3.2. Type: .2.4. Radio interference suppression equipment2.4.1. Make: .2.4.2. Type: .>END OF GRAPHIC>Appendix 2MODEL (maximum format: A4 (210 × 297 mm)) EC TYPE-APPROVAL CERTIFICATE >START OF GRAPHIC>Stamp of administrationCommunication concerning the- type-approval (1),- extension of type-approval (1),- refusal of type-approval (1),- withdrawal of type-approval (1),of a type of a vehicle/component/separate technical unit (1) with regard to Directive . . ./. . ./EEC, as last amended by Directive . . ./. . ./EC.Type-approval number: .Reason for extension: .SECTION I0.1. Make (trade name of manufacturer): .0.2. Type and general commercial description(s): .0.3. Means of identification of type if marked on the vehicle/component/separate technical unit (1) (2): .0.3.1. Location of that marking: .0.4. Category of vehicle (1) (3): .0.5. Name and address of manufacturer: .0.7. In the case of components and separate technical units, location and method of affixing of the EC approval mark: .0.8. Address(es) of assembly plant(s): .SECTION II1. Additional information (where applicable): see Addendum2. Technical service responsible for carrying out the tests: .3. Date of test report: .4. Number of test report: .5. Remarks (if any): see Addendum6. Place: .7. Date: .8. Signature: .9. The index to the information package lodged with the approval authority, which may be obtained on request, is attached.(1) Delete where not applicable.(2) If the means of identification of type contains characters not relevant to describe the vehicle, component or separate technical unit types covered by this type-approval certificate such characters shall be represented in the documentation by the symbol: "?" (e.g. ABC??123??).(3) As defined in Annex II Section A to Directive 70/156/EEC.>END OF GRAPHIC>Addendum to EC type-approval certificate No . . . concerning the type-approval of a vehicle with regard to Directive 80/1269/EEC, as last amended by Directive . . ./. . ./EC >START OF GRAPHIC>1. Additional information1.1. Engine .1.1.1. Manufacturer's engine code: . (as marked on the engine, or other means of identification)1.1.2. Engine capacity: .1.1.3. Fuel: diesel oil/petrol/LPG/any other (1)1.1.4. Maximum net power: . . . . . . . . . . . . . . . . . . . . . . kW at . min-15. Remarks: .(1) Delete where not applicable.>END OF GRAPHIC>`ANNEX II 10. The entire text above item 1 is replaced by the new title 'TEST REPORT`.11. Items 1 to 4 are deleted.12. Items 5 and 6 become items 1 and 2 respectively.13. Item 2.1 (former item 6.1):In the table 'Power to be added . . . (see Table 1, note 5)` is replaced by 'Power to be added for auxiliary equipment fitted on the engine in excess of Table 1 in Annex I (see item 1 in the Addendum to Appendix 1 of Annex I). Power to be subtracted when fan not fitted (see Table 1 in Annex I, note 5).`14. Items 7 to 14 are deleted.(1*) The item numbers and footnotes used in this information document correspond to those set out in Annex I to Directive 70/156/EEC. Items not relevant for the purpose of this Directive are omitted.