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31995L0003

Commission Directive 95/3/EC of 14 February 1995 amending Directive 90/128/EEC relating to plastics materials and articles intended to come into contact with foodstuffs

Official Journal L 041 , 23/02/1995 P. 0044 - 0053

COMMISSION DIRECTIVE 95/3/EC of 14 February 1995 amending Directive 90/128/EEC relating to plastics materials and articles intended to come into contact with foodstuffsTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Community,  Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (1), and in particular Article 3 thereof,  After consulting the Scientific Committee for Food,  Whereas the Community measures envisaged by this Directive are not only necessary but also indispensable for the attainment of the objectives of the internal market; whereas those objectives cannot be achieved by Member States individually; whereas,  furthermore, their attainment at Community level is already provided for by Directive 89/109/EEC;  Whereas Commission Directive 90/128/EEC (2), as last amended by Directive 93/9/EEC (3), and in particular Article 3 (4) thereof, provides for the revision of Annex II and particularly Section B;  Whereas, on the basis of the information available, certain substances provisionally admitted at national level may be included in the Community list;  Whereas certain substances provisionally admitted at national level may continue to be permitted for a further specified period, since the data requested by the Scientific Committee for Food are not yet available although the requisite studies are in  progress or are planned;  Whereas other substances have been requested for use following the adoption of Directive 90/128/EEC, and the technical data supplied permit their inclusion in the Community list;  Whereas, for certain substances, the restrictions already set out should be amended according to the information available;  Whereas it is necessary to extend this list to additives in order to obtain a more complete harmonization of this sector;  Whereas the number of substances to be included in a complete list of additives is so large that it is necessary to proceed step by step, although the final step will be a complete list of additives (positive list);  Whereas the list which appears in this Directive is an initial, incomplete list which, therefore, does not contain all the substances which are currently accepted in one or more Member States and then these substances can continue to be regulated by  national laws pending a decision on inclusion in the Community list;  Whereas certain substances may require specific rules concerning purity criteria which are not yet included in this Directive, and therefore this aspect continues to be governed by national laws pending a decision at Community level;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,  HAS ADOPTED THIS DIRECTIVE:   Article 1  Directive 90/128/EEC is amended as follows:  1. The following Article 3a is inserted:  'Article 3a An incomplete list of additives which may be used for the manufacture of plastics materials and articles is set out in Annex III.' 2. Annex II is amended as shown in Annex I to this Directive.  3. Annex II to this Directive is added as Annex III.   Article 2  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 April 1996. They shall immediately inform the Commission thereof.  Member States shall:  - permit, as from 1 April 1996, the trade in and use of plastic materials and articles intended to come into contact with foodstuffs complying with this Directive;  - prohibit, as from 1 April 1998, the trade in and use of plastic materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive.  2. 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.   Article 3  This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Communities.  Done at Brussels, 14 February 1995.  For the Commission Martin BANGEMANN Member of the Commission  (1) OJ No L 40, 11. 2. 1989, p. 38.  (2) OJ No L 75, 21. 3. 1990, p. 19, corrected by OJ No L 349, 13. 12. 1990, p. 26.  (3) OJ No L 90, 14. 4. 1993, p. 26.      ANNEX I Annex II to Directive 90/128/EEC is amended as follows:  (a) In paragraph 4, the words 'as regards the purity criteria' are added after 'quality'.  (b) Section A is amended as shown in Appendices 1, 2 and 3.  (c) Section B is amended as shown in Appendix 4.  Appendix 1  List of monomers and other starting substances added to Section A   "" ID="1">12789> ID="2">007664-41-7> ID="3">Ammonia"> ID="1">14411> ID="2">008001-79-4> ID="3">Castor oil"> Appendix 2  List of monomers and other starting substances in Section A for which the content of the column 'Restrictions' is modified   "" ID="1">24130> ID="2">008050-09-7> ID="3">Rosin gum> ID="4">See 'Rosin'"> ID="1">24887> ID="2">006362-79-4> ID="3">5-Sulphoisophthalic acid, monosodium salt> ID="4">SML = 5 mg/kg"> Appendix 3  List of monomers and other starting substances deleted   "" ID="1">14410> ID="2">008001-79-4> ID="3">Castor oil (food grade quality)"> Appendix 4  List of monomers and other starting substances transferred to Section A   "" ID="1">10660> ID="2">015214-89-8> ID="3">2-Acrylamido-2-methylpropanesulphonic acid> ID="4">SML = 0,05 mg/kg"> ID="1">15070> ID="2">001647-16-1> ID="3">1,9-Decadiene> ID="4">SML = 0,05 mg/kg"> ID="1">17050> ID="2">000104-76-7>  ID="3">2-Ethyl-1-hexanol> ID="4">SML = 30 mg/kg"> ID="1">19270> ID="2">000097-65-4> ID="3">Itaconic acid"> ID="1">26140> ID="2">000075-38-7> ID="3">Vinylidene fluoride> ID="4">SML = 5 mg/kg">    ANNEX II 'ANNEX III INCOMPLETE LIST OF ADDITIVES WHICH MAY BE USED IN THE MANUFACTURE OF PLASTICS MATERIALS AND ARTICLES General introduction 1. This Annex contains the list of:  (a) substances which are incorporated into plastics to achieve a technical effect in the finished product. They are intended to be present in the finished articles;  (b) substances used to provide a suitable medium in which polymerization occurs (e.g. emulsifiers, surfactants, buffering agents etc.).  The list does not include the substances which directly influence the formation of polymers (e.g. the catalytic system).  2. The list does not include the salts (including double salts and acid salts) of aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and zinc of the authorized acids, phenols or alcohols which are also authorized. However, names containing  ". . .acid(s), salts" appear in the lists if the corresponding free acid(s) is (are) not mentioned. In such cases the meaning of the term "salts" is "salts of aluminium ammonium, calcium, iron, magnesium, potassium, sodium and zinc".  3. The list does not include the following substances although they may be present:  (a) substances which could be present in the finished product such as:  - impurities in the substances used,  - reaction intermediates,  - decomposition products;  (b) mixtures of the authorized substances.  The materials and articles which contain the substances indicated in (a) and (b) shall comply with the requirements stated in Article 2 of Directive 89/109/EEC.  4. Substances shall be of good technical quality as regards the purity criteria.  5. The list contains the following information:  - column 1 (PM-REF No): the EEC packaging material reference number of the substances on the list,  - column 2 (CAS No): the CAS (Chemical Abstracts Service) registry number,  - column 3 (Name): the chemical name,  - column 4 (Restrictions). These may include:  - specific migration limit (SML),  - maximum permitted quantity of the "residual", substance in the material or article (QM),  - any other restriction specifically mentioned.  6. If a substance appearing on the list as an individual compound is also covered by a generic term, the restrictions applying to this substance shall be those indicated for the individual compound.  7. Where there is any inconsistency between the CAS number and the chemical name, the chemical name shall take precedence over the CAS number. If there is an inconsistency between the CAS number reported in Einecs and the CAS registry, the CAS number in  the CAS registry shall apply.  Incomplete list of additives  "" ID="1">30000> ID="2">000064-19-7> ID="3">Acetic acid"> ID="1">30045> ID="2">000123-86-4> ID="3">Acetic acid, butyl ester"> ID="1">30140> ID="2">000141-78-6> ID="3">Acetic acid, ethyl ester"> ID="1">30280> ID="2">000108-24-7> ID="3">Acetic  anhydride"> ID="1">30295> ID="2">000067-64-1> ID="3">Acetone"> ID="1">30370> ID="2">-> ID="3">Acetylacetic acid, salts"> ID="1">30400> ID="2">-> ID="3">Acetylated glycerides"> ID="1">30960> ID="2">-> ID="3">Acids, aliphatic, monocarboxylic (C6-C22),  esters with polyglycerol"> ID="1">31328> ID="2">-> ID="3">Acids, fatty, from animal or vegetable food fats and oils"> ID="1">31730> ID="2">000124-04-9> ID="3">Adipic acid"> ID="1">33120> ID="2">-> ID="3">Alcohols, aliphatic, monohydric, saturated,  linear, primary (C4-C24)"> ID="1">33350> ID="2">009005-32-7> ID="3">Alginic acid"> ID="1">34480> ID="2">-> ID="3">Aluminium fibers, flakes and powders"> ID="1">34560> ID="2">021645-51-2> ID="3">Aluminium hydroxide"> ID="1">34690> ID="2">011097-59-9>  ID="3">Aluminium magnesium carbonate hydroxide"> ID="1">34720> ID="2">001344-28-1> ID="3">Aluminium oxide"> ID="1">35120> ID="2">013560-49-1> ID="3">3-Aminocrotonic acid, diester with thiobis (2-hydroxyethyl) ether"> ID="1">35320> ID="2">007664-41-7>  ID="3">Ammonia"> ID="1">35440> ID="2">012124-97-9> ID="3">Ammonium bromide"> ID="1">35600> ID="2">001336-21-6> ID="3">Ammonium hydroxide"> ID="1">35840> ID="2">000506-30-9> ID="3">Arachidic acid"> ID="1">35845> ID="2">007771-44-0> ID="3">Arachidonic  acid"> ID="1">36000> ID="2">000050-81-7> ID="3">Ascorbic acid"> ID="1">36080> ID="2">000137-66-6> ID="3">Ascorbyl palmitate"> ID="1">36160> ID="2">010605-09-1> ID="3">Ascorbyl stearate"> ID="1">36880> ID="2">008012-89-3> ID="3">Beeswax">  ID="1">36960> ID="2">003061-75-4> ID="3">Behenamide"> ID="1">37040> ID="2">000112-85-6> ID="3">Behenic acid"> ID="1">37280> ID="2">001302-78-9> ID="3">Bentonite"> ID="1">37600> ID="2">000065-85-0> ID="3">Benzoic acid"> ID="1">37680>  ID="2">000136-60-7> ID="3">Benzoic acid, butyl ester"> ID="1">37840> ID="2">000093-89-0> ID="3">Benzoic acid, ethyl ester"> ID="1">38080> ID="2">000093-58-3> ID="3">Benzoic acid, methyl ester"> ID="1">38160> ID="2">002315-68-6> ID="3">Benzoic acid,  propyl ester"> ID="1">38950> ID="2">079072-96-1> ID="3">Bis (4-ethylbenzylidene) sorbitol"> ID="1">39890> ID="2">087826-41-3> ID="3">Bis (methylbenzylidene) sorbitol"> ID="2">069158-41-4"> ID="2">054686-97-4"> ID="1">40400> ID="2">010043-11-5>  ID="3">Boron nitride"> ID="1">40570> ID="2">000106-97-8> ID="3">Butane"> ID="1">41040> ID="2">005743-36-2> ID="3">Calcium butyrate"> ID="1">41280> ID="2">001305-62-0> ID="3">Calcium hydroxide"> ID="1">41520> ID="2">001305-78-8> ID="3">Calcium  oxide"> ID="1">41600> ID="2">012004-14-7> ID="3">Calcium sulphoaluminate"> ID="2">037293-22-4"> ID="1">41760> ID="2">008006-44-8> ID="3">Candelilla wax"> ID="1">41960> ID="2">000124-07-2> ID="3">Caprylic acid"> ID="1">42160> ID="2">000124-38-9>  ID="3">Carbon dioxide"> ID="1">42500> ID="2">-> ID="3">Carbonic acid, salts"> ID="1">42640> ID="2">009000-11-7> ID="3">Carboxymethylcellulose"> ID="1">42720> ID="2">008015-86-9> ID="3">Carnauba wax"> ID="1">42800> ID="2">009000-71-9>  ID="3">Casein"> ID="1">42960> ID="2">064147-40-6> ID="3">Castor oil, dehydrated"> ID="1">43200> ID="2">-> ID="3">Castor oil, mono- and diglycerides"> ID="1">43280> ID="2">009004-34-6> ID="3">Cellulose"> ID="1">43300> ID="2">009004-36-8>  ID="3">Cellulose acetate butyrate"> ID="1">43360> ID="2">068442-85-3> ID="3">Celulose, regenerated"> ID="1">43440> ID="2">008001-75-0> ID="3">Ceresin"> ID="1">44160> ID="2">000077-92-9> ID="3">Citric acid"> ID="1">44640> ID="2">000077-93-0>  ID="3">Citric acid, triethyl ester"> ID="1">45280> ID="2">-> ID="3">Cotton fibers"> ID="1">45560> ID="2">014464-46-1> ID="3">Cristobalite"> ID="1">45760> ID="2">000108-91-8> ID="3">Cyclohexylamine"> ID="1">45920> ID="2">009000-16-2> ID="3">Dammar">  ID="1">45940> ID="2">000334-48-5> ID="3">n-Decanoic acid"> ID="1">46070> ID="2">010016-20-3> ID="3">alpha-Dextrin"> ID="1">46080> ID="2">007585-39-9> ID="3">beta-Dextrin"> ID="1">46375> ID="2">061790-53-2> ID="3">Diatomaceous earth"> ID="1">46480>  ID="2">032647-67-9> ID="3">Dibenzylidene sorbitol"> ID="1">46790> ID="2">004221-80-1> ID="3">3,5-Di-tert-butyl-4-hydroxybenzoic acid, 2,4-di-tert-butylphenyl ester"> ID="1">46800> ID="2">067845-93-6> ID="3">3,5-Di-tert-butyl-4-hydroxybenzoic acid,  hexadecyl ester"> ID="1">46870> ID="2">003135-18-0> ID="3">3,5-Di-tert-butyl-4-hydroxybenzylphosphonic acid, dioctadecyl ester"> ID="1">47440> ID="2">000461-58-5> ID="3">Dicyanodiamide"> ID="1">49540> ID="2">000067-68-5> ID="3">Dimethyl sulphoxide">  ID="1">51200> ID="2">000126-58-9> ID="3">Dipentaerythritol"> ID="1">51760> ID="2">025265-71-8> ID="3">Dipropyleneglycol"> ID="2">000110-98-5"> ID="1">52640> ID="2">016389-88-1> ID="3">Dolomite"> ID="1">52730> ID="2">000112-86-7> ID="3">Erucic  acid"> ID="1">52800> ID="2">000064-17-5> ID="3">Ethanol"> ID="1">53270> ID="2">037205-99-5> ID="3">Ethylcarboxymethylcellulose"> ID="1">53280> ID="2">009004-57-3> ID="3">Ethylcellulose"> ID="1">53360> ID="2">000110-31-6> ID="3">N,N&  prime;-Ethylenebisoleamide"> ID="1">53440> ID="2">005518-18-3> ID="3">N,N& prime;-Ethylenebispalmitamide"> ID="1">53520> ID="2">000110-30-5> ID="3">N,N& prime;-Ethylenebisstearamide"> ID="1">53600> ID="2">000060-00-4>  ID="3">Ethylenediaminetetraacetic acid"> ID="1">54005> ID="2">005136-44-7> ID="3">Ethylene-N-palmitamide-N& prime;-stearamide"> ID="1">54260> ID="2">009004-58-4> ID="3">Ethylhydroxyethylcellulose"> ID="1">54270> ID="2">->  ID="3">Ethylhydroxymethylcellulose"> ID="1">54280> ID="2">-> ID="3">Ethylhydroxypropylcellulose"> ID="1">54450> ID="2">-> ID="3">Fats and oils, from animal or vegetable food sources"> ID="1">54480> ID="2">-> ID="3">Fats and oils, hydrogenated, from  animal or vegetable food sources"> ID="1">55040> ID="2">000064-18-6> ID="3">Formic acid"> ID="1">55120> ID="2">000110-17-8> ID="3">Fumaric acid"> ID="1">55190> ID="2">029204-02-2> ID="3">Gadoleic acid"> ID="1">55440> ID="2">009000-70-8>  ID="3">Gelatin"> ID="1">55680> ID="2">000110-94-1> ID="3">Glutaric acid"> ID="1">55920> ID="2">000056-81-5> ID="3">Glycerol"> ID="1">56020> ID="2">099880-64-5> ID="3">Glycerol dibehenate"> ID="1">56360> ID="2">-> ID="3">Glycerol, esters with acetic  acid"> ID="1">56487> ID="2">-> ID="3">Glycerol, esters with butyric acid"> ID="1">56490> ID="2">-> ID="3">Glycerol, esters with erucic acid"> ID="1">56495> ID="2">-> ID="3">Glycerol, esters with 12-hydroxystearic acid"> ID="1">56500> ID="2">->  ID="3">Glycerol, esters with lauric acid"> ID="1">56510> ID="2">-> ID="3">Glycerol, esters with linoleic acid"> ID="1">56520> ID="2">-> ID="3">Glycerol, esters with myristic acid"> ID="1">56540> ID="2">-> ID="3">Glycerol, esters with oleic acid">  ID="1">56550> ID="2">-> ID="3">Glycerol, esters with palmitic acid"> ID="1">56565> ID="2">-> ID="3">Glycerol, esters with nonanoic acid"> ID="1">56570> ID="2">-> ID="3">Glycerol, esters with propionic acid"> ID="1">56580> ID="2">-> ID="3">Glycerol,  esters with ricinoleic acid"> ID="1">56585> ID="2">-> ID="3">Glycerol, esters with stearic acid"> ID="1">56610> ID="2">030233-64-8> ID="3">Glycerol monobehenate"> ID="1">56720> ID="2">026402-23-3> ID="3">Glycerol monohexanoate"> ID="1">56800>  ID="2">030899-62-8> ID="3">Glycerol monolaurate diacetate"> ID="1">56880> ID="2">026402-26-6> ID="3">Glycerol monooctanoate"> ID="1">57040> ID="2">-> ID="3">Glycerol monooleate, ester with ascorbic acid"> ID="1">57120> ID="2">-> ID="3">Glycerol  monooleate, ester with citric acid"> ID="1">57200> ID="2">-> ID="3">Glycerol monopalmitate, ester with ascorbic acid"> ID="1">57280> ID="2">-> ID="3">Glycerol monopalmitate, ester with citric acid"> ID="1">57600> ID="2">-> ID="3">Glycerol  monostearate, ester with ascrobic acid"> ID="1">57680> ID="2">-> ID="3">Glycerol monostearate, ester with citric acid"> ID="1">57920> ID="2">000620-67-7> ID="3">Glycerol triheptanoate"> ID="1">58300> ID="2">-> ID="3">Glycine, salts"> ID="1">58320>  ID="2">007782-42-5> ID="3">Graphite"> ID="1">58400> ID="2">009000-30-0> ID="3">Guar gum"> ID="1">58480> ID="2">009000-01-5> ID="3">Gum arabic"> ID="1">58720> ID="2">000111-14-8> ID="3">Heptanoic acid"> ID="1">59360> ID="2">000142-62-1>  ID="3">Hexanoic acid"> ID="1">59760> ID="2">019569-21-2> ID="3">Huntite"> ID="1">59990> ID="2">007647-01-0> ID="3">Hydrochloric acid"> ID="1">60030> ID="2">012072-90-1> ID="3">Hydromagnesite"> ID="1">60080> ID="2">012304-65-3> ID="3">Hydrotalcite">  ID="1">60160> ID="2">000120-47-8> ID="3">4-Hydroxybenzoic acid, ethyl ester"> ID="1">60180> ID="2">004191-73-5> ID="3">4-Hydroxybenzoic acid, isopropyl ester"> ID="1">60200> ID="2">000099-76-3> ID="3">4-Hydroxybenzoic acid, methyl ester">  ID="1">60240> ID="2">000094-13-3> ID="3">4-Hydroxybenzoic acid, propyl ester"> ID="1">60560> ID="2">009004-62-0> ID="3">Hydroxyethylcellulose"> ID="1">60880> ID="2">009032-42-2> ID="3">Hydroxyethylmethylcellulose"> ID="1">61120> ID="2">009005-27-0>  ID="3">Hydroxyethyl starch"> ID="1">61390> ID="2">037353-59-6> ID="3">Hydroxymethylcellulose"> ID="1">61680> ID="2">009004-64-2> ID="3">Hydroxypropylcellulose"> ID="1">61800> ID="2">009049-76-7> ID="3">Hydroxypropyl starch"> ID="1">61840>  ID="2">000106-14-9> ID="3">12-Hydroxystearic acid  "NoNo> ID="1">62140> ID="2">006303-21-5> ID="3">Hypophosphorous acid"> ID="1">62240> ID="2">001332-37-2> ID="3">Iron oxide"> ID="1">62450> ID="2">000078-78-4> ID="3">Isopentane"> ID="1">62640> ID="2">008001-39-6> ID="3">Japan wax"> ID="1">62720>  ID="2">001332-58-7> ID="3">Kaolin"> ID="1">62800> ID="2">-> ID="3">Kaolin, calcined"> ID="1">62960> ID="2">000050-21-5> ID="3">Lactic acid"> ID="1">63040> ID="2">000138-22-7> ID="3">Lactic acid, butyl ester"> ID="1">63280> ID="2">000143-07-7>  ID="3">Lauric acid"> ID="1">63760> ID="2">008002-43-5> ID="3">Lecithin"> ID="1">63840> ID="2">000123-76-2> ID="3">Levulinic acid"> ID="1">63920> ID="2">000557-59-5> ID="3">Lignoceric acid"> ID="1">64015> ID="2">000060-33-3> ID="3">Linoleic acid">  ID="1">64150> ID="2">028290-79-1> ID="3">Linolenic acid"> ID="1">64500> ID="2">-> ID="3">Lysine, salts"> ID="1">64640> ID="2">001309-42-8> ID="3">Magnesium hydroxide"> ID="1">64720> ID="2">001309-48-4> ID="3">Magnesium oxide"> ID="1">65020>  ID="2">006915-15-7> ID="3">Malic acid"> ID="1">65040> ID="2">000141-82-2> ID="3">Malonic acid"> ID="1">65520> ID="2">000087-78-5> ID="3">Mannitol"> ID="1">66200> ID="2">037206-01-2> ID="3">Methylcarboxymethylcellulose"> ID="1">66240>  ID="2">009004-67-5> ID="3">Methylcellulose"> ID="1">66640> ID="2">009004-59-5> ID="3">Methylethylcellulose"> ID="1">66695> ID="2">-> ID="3">Methylhydroxymethylcellulose"> ID="1">66700> ID="2">009004-65-3> ID="3">Methylhydroxypropylcellulose">  ID="1">67120> ID="2">012001-26-2> ID="3">Mica"> ID="1">67200> ID="2">001317-33-5> ID="3">Molybdenum disulphide"> ID="1">67840> ID="2">-> ID="3">Montanic acids and/or their esters with ethyleneglycol and/or with 1,3-butanediol and/or with glycerol">  ID="1">67850> ID="2">008002-53-7> ID="3">Montan wax"> ID="1">67891> ID="2">000544-63-8> ID="3">Myristic acid"> ID="1">68040> ID="2">003333-62-8> ID="3">7-[2H-Naphtho-(1,2-D)triazol-2-yl]-3-phenylcoumarin"> ID="1">68125> ID="2">068187-64-4>  ID="3">Nepheline syenite"> ID="1">69040> ID="2">000112-80-1> ID="3">Oleic acid"> ID="1">69760> ID="2">000143-28-2> ID="3">Oleyl alcohol"> ID="1">70000> ID="2">070331-94-1> ID="3">2,2& prime;-Oxamidobis[ethyl-3-(3,5-di-tert-butyl-4-hydroxyphenyl)-  propionate]"> ID="1">70240> ID="2">012198-93-5> ID="3">Ozokerite"> ID="1">70400> ID="2">000057-10-3> ID="3">Palmitic acid"> ID="1">71020> ID="2">000373-49-9> ID="3">Palmitoleic acid"> ID="1">71440> ID="2">009000-69-5> ID="3">Pectin"> ID="1">71600>  ID="2">000115-77-5> ID="3">Pentaerythritol"> ID="1">71680> ID="2">006683-19-8> ID="3">Pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)- propionate]"> ID="1">71720> ID="2">000109-66-0> ID="3">Pentane"> ID="1">72640> ID="2">007664-38-2>  ID="3">Phosphoric acid"> ID="1">74240> ID="2">031570-04-4> ID="3">Phosphorous acid, tris(2,4-di-tert-butylphenyl)ester"> ID="1">74480> ID="2">000088-99-3> ID="3">o-Phthalic acid"> ID="1">76320> ID="2">000085-44-9> ID="3">Phthalic anhydride">  ID="1">76720> ID="2">009016-00-6> ID="3">Polydimethylsiloxane"> ID="2">063148-62-9"> ID="1">76960> ID="2">025322-68-3> ID="3">Polyethyleneglycol"> ID="1">77600> ID="2">061788-85-0> ID="3">Polyethyleneglycol ester of hydrogenated castor oil">  ID="1">77702> ID="2">-> ID="3">Polyethyleneglycol esters of aliphatic monocarboxylic acids (C6-C22), and their ammonium and sodium sulphates"> ID="1">79040> ID="2">009005-64-5> ID="3">Polyethyleneglycol sorbitan monolaurate"> ID="1">79120>  ID="2">009005-65-6> ID="3">Polyethyleneglycol sorbitan monooleate"> ID="1">79200> ID="2">009005-66-7> ID="3">Polyethyleneglycol sorbitan monopalmitate"> ID="1">79280> ID="2">009005-67-8> ID="3">Polyethyleneglycol sorbitan monostearate"> ID="1">79360>  ID="2">009005-70-3> ID="3">Polyethyleneglycol sorbitan trioleate"> ID="1">79440> ID="2">009005-71-4> ID="3">Polyethyleneglycol sorbitan tristearate"> ID="1">80240> ID="2">029894-35-7> ID="3">Polyglycerol ricinoleate"> ID="1">80640> ID="2">->  ID="3">Polyoxyalkyl(C2-C4)dimethylpolysiloxane"> ID="1">80720> ID="2">008017-16-1> ID="3">Polyphosphoric acids"> ID="1">81520> ID="2">007758-02-3> ID="3">Potassium bromide"> ID="1">81600> ID="2">001310-58-3> ID="3">Potassium hydroxide">  ID="1">81840> ID="2">000057-55-6> ID="3">1,2-Propanediol"> ID="1">81882> ID="2">000067-63-0> ID="3">2-Propanol"> ID="1">82000> ID="2">000079-09-4> ID="3">Propionic acid"> ID="1">82080> ID="2">009005-37-2> ID="3">1,2-Propyleneglycol alginate">  ID="1">82240> ID="2">022788-19-8> ID="3">1,2-Propyleneglycol dilaurate"> ID="1">82400> ID="2">000105-62-4> ID="3">1,2-Propyleneglycol dioleate"> ID="1">82560> ID="2">033587-20-1> ID="3">1,2-Propyleneglycol dipalmitate"> ID="1">82720>  ID="2">006182-11-2> ID="3">1,2-Propyleneglycol distearate"> ID="1">82800> ID="2">027194-74-7> ID="3">1,2-Propyleneglycol monolaurate"> ID="1">82960> ID="2">001330-80-9> ID="3">1,2-Propyleneglycol monooleate"> ID="1">83120> ID="2">029013-28-3>  ID="3">1,2-Propyleneglycol monopalmitate"> ID="1">83300> ID="2">001323-39-3> ID="3">1,2-Propyleneglycol monostearate"> ID="1">83320> ID="2">-> ID="3">Propylhydroxyethylcellulose"> ID="1">83325> ID="2">-> ID="3">Propylhydroxymethylcellulose">  ID="1">83330> ID="2">-> ID="3">Propylhydroxypropylcellulose"> ID="1">83440> ID="2">002466-09-3> ID="3">Pyrophosphoric acid"> ID="1">83455> ID="2">013445-56-2> ID="3">Pyrophosphorous acid"> ID="1">83460> ID="2">012269-78-2> ID="3">Pyrophyllite">  ID="1">83470> ID="2">014808-60-7> ID="3">Quartz"> ID="1">83610> ID="2">073138-82-6> ID="3">Resin acids and rosin acids"> ID="1">83840> ID="2">008050-09-7> ID="3">Rosin"> ID="1">84000> ID="2">008050-31-5> ID="3">Rosin, ester with glycerol">  ID="1">84080> ID="2">008050-26-8> ID="3">Rosin, ester with pentaerythritol"> ID="1">84210> ID="2">065997-06-0> ID="3">Rosin, hydrogenated"> ID="1">84240> ID="2">065997-13-9> ID="3">Rosin, hydrogenated, ester with glycerol"> ID="1">84320>  ID="2">008050-15-5> ID="3">Rosin, hydrogenated, ester with methanol"> ID="1">84400> ID="2">064365-17-9> ID="3">Rosin, hydrogenated, ester with pentaerythritol"> ID="1">84560> ID="2">009006-04-6> ID="3">Rubber, natural"> ID="1">84640>  ID="2">000069-72-7> ID="3">Salicylic acid"> ID="1">85600> ID="2">-> ID="3">Silicates, natural"> ID="1">85980> ID="2">-> ID="3">Silicic acid, salts"> ID="1">86000> ID="2">-> ID="3">Silicic acid, silylated"> ID="1">86160> ID="2">000409-21-2>  ID="3">Silicon carbide"> ID="1">86240> ID="2">007631-86-9> ID="3">Silicon dioxide"> ID="1">86560> ID="2">007647-15-6> ID="3">Sodium bromide"> ID="1">86720> ID="2">001310-73-2> ID="3">Sodium hydroxide"> ID="1">87200> ID="2">000110-44-1> ID="3">Sorbic  acid"> ID="1">87280> ID="2">029116-98-1> ID="3">Sorbitan dioleate"> ID="1">87520> ID="2">062568-11-0> ID="3">Sorbitan monobehenate"> ID="1">87600> ID="2">001338-39-2> ID="3">Sorbitan monolaurate"> ID="1">87680> ID="2">001338-43-8> ID="3">Sorbitan  monooleate"> ID="1">87760> ID="2">026266-57-9> ID="3">Sorbitan monopalmitate"> ID="1">87840> ID="2">001338-41-6> ID="3">Sorbitan monostearate"> ID="1">87920> ID="2">061752-68-9> ID="3">Sorbitan tetrastearate"> ID="1">88080> ID="2">026266-58-0>  ID="3">Sorbitan trioleate"> ID="1">88160> ID="2">054140-20-4> ID="3">Sorbitan tripalmitate"> ID="1">88240> ID="2">026658-19-5> ID="3">Sorbitan tristearate"> ID="1">88320> ID="2">000050-70-4> ID="3">Sorbitol"> ID="1">88600> ID="2">026836-47-5>  ID="3">Sorbitol monostearate"> ID="1">88800> ID="2">009005-25-8> ID="3">Starch, edible"> ID="1">88880> ID="2">068412-29-3> ID="3">Starch, hydrolysed"> ID="1">89040> ID="2">000057-11-4> ID="3">Stearic acid"> ID="1">90720> ID="2">058446-52-9>  ID="3">Stearoylbenzoylmethane"> ID="1">90800> ID="2">005793-94-2> ID="3">Stearoyl-2-lactylic acid, calcium salt"> ID="1">90960> ID="2">000110-15-6> ID="3">Succinic acid"> ID="1">91200> ID="2">000126-13-6> ID="3">Sucrose acetate isobutyrate">  ID="1">91360> ID="2">000126-14-7> ID="3">Sucrose octaacetate"> ID="1">91840> ID="2">007704-34-9> ID="3">Sulphur"> ID="1">91920> ID="2">007664-93-9> ID="3">Sulphuric acid"> ID="1">92080> ID="2">014807-96-6> ID="3">Talc"> ID="1">92160>  ID="2">000087-69-4> ID="3">Tartaric acid"> ID="1">92195> ID="2">-> ID="3">Taurine, salts"> ID="1">92205> ID="2">057569-40-1> ID="3">Terephthalic acid, diester with 2,2& prime;-methylenebis(4-methyl-6-tert-butylphenol)"> ID="1">92350>  ID="2">000112-60-7> ID="3">Tetraethyleneglycol"> ID="1">92640> ID="2">000102-60-3> ID="3">N,N,N& prime;,N& prime;-Tetrakis(2-hydroxypropyl)ethylenediamine"> ID="1">93440> ID="2">013463-67-7> ID="3">Titanium dioxide"> ID="1">93520> ID="2">000059-02-9>  ID="3">alpha-Tocopherol"> ID="2">010191-41-0"> ID="1">93680> ID="2">009000-65-1> ID="3">Tragacanth gum"> ID="1">94320> ID="2">000112-27-6> ID="3">Triethyleneglycol"> ID="1">95200> ID="2">001709-70-2>  ID="3">1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl)benzene"> ID="1">95905> ID="2">013983-17-0> ID="3">Wollastonite"> ID="1">95920> ID="2">-> ID="3">Wood flour and fibers, untreated"> ID="1">95935> ID="2">011138-66-2> ID="3">Xanthan  gum"> ID="1">96190> ID="2">020427-58-1> ID="3">Zinc hydroxide"> ID="1">96240> ID="2">001314-13-2> ID="3">Zinc oxide"> ID="1">96320> ID="2">001314-98-3> ID="3">Zinc sulphide'">


Avis juridique important

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31989L0342

Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens

Official Journal L 142 , 25/05/1989 P. 0014 - 0015 Finnish special edition: Chapter 13 Volume 19 P. 0012  Swedish special edition: Chapter 13 Volume 19 P. 0012

COUNCIL DIRECTIVE of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens (89/342/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Hacing regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas disparities in the provisions laid down by law, regulation or administrative action by Member States may hinder trade in immunological products within the Community;  Whereas the essential aim of any rules governing the production, distribution or use of medicinal products must be to safeguard public health;  Whereas Directive 65/65/EEC (4), as last amended by Directive 87/21/EEC (5), and Second Directive 75/319/EEC (6), as last amended by Directive 83/570/EEC (7), on the approximation of provisions laid down by law, regulation or administrative action  relating to proprietary medicinal products, although appropriate, are inadequate for immunological medicinal products consisting of vaccines, toxins or serums and allergens;  Whereas, in accordance with Article 5 of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology  (8), the Commission is required to submit proposals to harmonize, along the lines of Directive 75/319/EEC, the conditions for authorizing the manufacture and placing on the market of immunological medicinal products before 22 December 1987;   16. 5. 1989.   Whereas, before an authorization to market an immunological product can be granted, the manufacturer must demonstrate his ability to attain batch-to-batch consistency;  Whereas the Commission should be empowered to adopt any necessary changes in the requirements for the testing of proprietary medicinal products set out in the Annex to Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the  Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (9), as last amended by Directive 87/19/EEC (10), to take account of the special nature of  immunological medicinal products in close cooperation with the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Proprietary Medicinal Products Sector, thus ensuring greater  quality, safety and efficacy,  HAS ADOPTED THIS DIRECTIVE:    Article 1 1.  In derogation from Article 34 of Directive 75/319/EEC, and subject to the provisions of this Directive, Directives 65/65/EEC and 75/319/EEC shall apply to immunological medicinal products for human use consisting of vaccines, toxins or  serums and allergen products.  2.  For the purposes of this Directive, the following definitions shall apply:  - 'allergen product' shall mean any product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent,  - vaccines, toxins and serums shall have the meaning assigned to them in the Annex to Directive 75/319/EEC.  Article 2 1.  The quantitative particulars of an immunological medicinal product shall be expressed by mass or by international units or by units of biological activity or by specific protein content, where possible, as appropriate to the product  concerned.  ¹ 2.  In respect of immunological products in Directives 65/65/EEC and 75/319/EEC the expressions 'qualitative and quantitative particulars of the constitutents' shall also include particulars relating to biological activity or to protein content and  'qualitative and quantitative composition' shall include the composition of the product expressed in terms of biological activity or of protein content.  3.  Whenever the name of an immunological medicinal product is expressed, the common or scientific name of the active constituents shall also be included.  Article 3 In addition to the information referred to in Article 4a of Directive 65/65/EEC the summary of product characteristics referred to in point 9 of the second subparagraph of Article 4 of Directive 65/65/EEC shall contain the following  information in respect of immunological products:  - under point 5.4, information regarding any special precautions to be taken by persons handling the immunological medicinal product and persons administering it to patients, together with any precautions to be taken by the patient.  Article 4 1.  Member States shall take all appropriate steps to ensure that the manufacturing processes used in the manufacture of immunological products are properly validated and attain batch-to-batch consistency.  2.  For the purpose of implementing Article 8 of Directive 65/65/EEC and Article 27 of Directive 75/319/EEC, Member States may require manufacturers of immunological products to submit to a competent authority copies of all the control reports signed by  the qualified person in accordance with Article 22 of Directive 75/319/EEC.  3.  Where it considers it necessary in the interests of public health, a Member State may require persons responsible for marketing:  - live vaccines,  - immunological medicinal products used in the primary immunization of infants or of other groups at risk,  - immunological medicinal products used in public health immunization programmes,  - new immunological medicinal products or immunological medicinal products manufactured using new or altered kinds of technology or new for a particular manufacturer, during a transitional period normally specified in the marketing authorization,  to submit samples from each batch of the bulk and/or finished product for examination by a State laboratory or a laboratory designated for that purpose before release on to the market unless, in the case of a batch manufactured in another Member State,  the competent authority of another Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications. Member States shall ensure that any such examiniation is completed within 60 days of the  receipt of the samples.  Article 5 Any amendents which are necesssary in the testing requirements for medicinal products set out in the Annex to Directive 75/318/EEC to take account of the extension of the scope of Directives 65/65/EEC and 75/319/EEC to cover immunological  medicinal products shall be adopted in accordance with the procedure laid down in Article 2c of Directive 75/318/EEC.  Article 6 1.  Except as provided in paragraph 2, Member States shall take the necessary measures to comply with this Directive not later than 1 January 1992. They shall forthwith inform the Commission thereof.  2.  If the amendments to Directive 75/318/EEC referred to in Article 5 have not been adopted by the date referred to in paragraph 1, this Directive shall come into force on the same date as those amendments.  3.  Requests for marketing authorizations for products covered by this Directive lodged after the date on which it comes into force must comply with the provisions of this Directive.  4.  This Directive shall be progressively extended to existing immunological medicinal products before 31 December 1992.  Article 7 This Directive is addressed to the Member States.   Done at Brussels, 3 May 1989.  For the Council The President P. SOLBES  (1) OJ No C 36, 8. 2. 1988, p. 25. (2) OJ No C 290, 14. 11. 1988, p. 131; OJ No C 120, (3) OJ No C 208, 8. 8. 1988, p. 64. (4) OJ No 22, 9. 2. 1965, p. 369/65. (5) OJ No L 15, 17. 1. 1987, p. 36. (6) OJ No L 147, 9. 6. 1975, p. 13. (7) OJ No L 332, 28. 11. 1983, p. 1. (8) OJ No L 15, 17. 1. 1987, p. 38.(9) OJ No L 147, 9. 6. 1975, p. 1. (10) OJ No L 15, 17. 1. 1987, p. 31.