Avis juridique important

|

31993L0093

Council Directive 93/93/EEC of 29 October 1993 on the masses and dimensions of two or three-wheel motor vehicles

Official Journal L 311 , 14/12/1993 P. 0076 - 0082

COUNCIL 93/93/EEC DIRECTIVE of 29 October 1993 on the masses and dimensions of two or three-wheel motor vehiclesTHE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles(1) ,  Having regard to the proposal from the Commission(2) ,  In cooperation with the European Parliament(3) ,  Having regard to the opinion of the Economic and Social Committee(4) ,  Whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; whereas the measures necessary for its operation should be adopted;  Whereas with regard to their masses and dimensions, in each Member State two or three-wheel vehicles must display certain technical characteristics laid down by mandatory provisions which differ from one Member State to another; whereas, as a result of  their differences, such provisions constitute barrier to trade within the Community;  Whereas those barriers to the operation of the internal market may be removed if the same requirements are adopted by all the Member States in place of their national rules;  Whereas it is necessary to draw up harmonized requirements concerning the masses and dimensions of two or three-wheel motor vehicles in order to enable the type-approval and component type-approval procedures laid down in Directive 92/61/EEC to be  applied for each type of such vehicle;  Whereas, given the scale and impact of the action proposed in the sector in question, the Community measures covered by this Directive are necessary, indeed essential, to achieve the aim in view, which is to establish Community vehicle type-approval;  whereas that aim cannot be adequately achieved by the Member States individually;  Whereas the provisions of this Directive should not oblige those Member States which do not allow two-wheel motor vehicles on their territory to tow a trailer to amend their rules,  HAS ADOPTED THIS DIRECITVE:   Article 1  This Directive together with its Annex shall apply to the masses and dimensions of all types of vehicle as defined in Article 1 of Directive 92/61/EEC.   Article 2  The procedure for the granting of component type-approval in respect of the masses and dimensions of a type of two or three-wheel motor vehicle and the conditions governing the free movement of such vehicles shall be as laid down in Chapters  II and III of Directive 92/61/EEC.   Article 3  Any amendments necessary to adapt the requirements of the Annexes to technical progress shall be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC(5) .   Article 4  1.  Member States shall adopt and publish the provisions necessary to comply with this Directive before 1 May 1993. They shall forthwith inform the Commission thereof.  When the Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the  Member States.  2.  From the date mentioned in paragraph 1 Member States may not, for reasons connected with masses and dimensions, prohibit the initial entry into service of vehicles which conform to this Directive.  They shall apply the provisions referred to in paragraph 1 as from 1 November 1995.  3.  Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.   Article 5  This Directive is addressed to the Member States.  Done at Brussels, 19 October 1993.  For the Council The President R. URBAIN  (1) OJ No L 225, 10. 8. 1992, p. 72.  (2) OJ No C 293, 9. 11. 1992, p. 1.  (3) OJ No C 337, 21. 12. 1992, p. 104 and Decision of 27 October 1993 (not yet published in the Official Journal).  (4) OJ No C 73, 15. 3. 1993, p. 22.  (5) 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 (OJ No L 42, 23. 2. 1970, p. 1), Directive as last amended by Directive  92/53/EEC (OJ No L 225, 10. 8. 1992, p. 1).      ANNEX   DEFINITIONS, GENERAL AND SPECIFIC REQUIREMENTS  1. DEFINITIONS For the purposes of this Directive.  1.1. length means the distance between two vertical planes perpendicular to the longitudinal plane of the vehicle and tangent to the front and rear of the vehicle, respectively. All components of the vehicle and, in particular, any fixed component extending towards  the front or rear (bumpers, mudguards, ect.) must be included within those two planes;  1.2. width means the distance between two planes parallel to the longitudinal plane of the vehicle and tangent to the vehicle on either side of that plane. All parts of the vehicle and, in particular, all fixed components extending sideways must be included within  those two planes, with the exception of the rear view mirror(s);  1.3. height means the distance between the plane supporting the vehicle and a parallel plane tangent to the upper part of the vehicle. All fixed components of the vehicle must be included within those two planes, with the exception of the rear view mirror(s);  1.4. longitudinal plane means a vertical plane running parallel to the straight-ahead direction of travel of the vehicle;  1.5. unladen mass means the mass of vehicle ready for normal use and equipped as follows:  - additional equipment required solely for the normal use under consideration,  - complete electrical equipment, including the lighting an light-signalling devices supplied by the manufacturer,  - instruments and devices required by the laws under which the unladen mass of the vehicle has been measured,  - the appropriate amounts of liquids in order to ensure the proper operation of all parts of the vehicle.  NB: the fuel and the fuel/oil mixture are not included in the measurement, but components such as the battery acid, the hydraulic fluid, the coolant and the engine oil must be included;  1.6. mass in running order means the unladen mass to which the mass of the following components is added:  - fuel: tank filled to at least 90 % of the capacity stated by the manufacturer,  - additional equipment normally supplied by the manufacturer in addition to that needed for normal operation (tool kit, luggage carrier, windscreen, protective equipment, etc).  NB: in the case of a vehicle operating with a fuel/oil mixture:  (a) when the fuel and oil are pre-mixed the word 'fuel' must be interpreted as meaning a pre-mixture of fuel and oil this type;  (b) when the fuel and oil are put in separately the word 'fuel' must be interpreted as meaning only the petrol. In this case, the oil is already included in the measurement of the unladen mass;  1.7. mass of the rider by convention, it is taken to be a round figure of 75 kg;  1.8. technically permissible maximum mass means the mass calculated by the manufacturer for specific operating conditions, taking account of factors such as the strength of the materials, loading capacity of the tyres, etc.;  1.9. maximum payload declared by the manufacturer means the load obtained by subtracting the mass defined in paragraph 1.6, with the mass of the rider (defined in paragraph 1.7), from the mass definded in paragraph 1.8.  2. GENERAL REQUIREMENTS The following requirements must be met during checks:  2.1. the dimensions must be measured with the vehicle at its unladen mass and its tyres inflated to the pressure recommended by the manufacturer for the unladen mass;  2.2. the vehicle must be in a vertical position and the wheels in a position corresponding to travel in a straight line;  2.3. all the wheels of the vehicle must be borne by the supporting plane, with the exception of any spare wheel.  3. SPECIFIC REQUIREMENTS 3.1. Maximum dimensions 3.1.1. The maximum dimensions authorized for two, three or four-wheel motor vehicles are as follows:  3.1.1.1. - length: 4,00 m,  3.1.1.2. - width: 1,00 m for two-wheel mopeds,  2,00 m for other vehicles,  3.1.1.3. - height: 2,50 m.  3.2. Maximum masses 3.2.1. The maximum mass for two-wheel motor vehicles is the technically permissible mass declared by the manufacturer.  3.2.2. The maximum unladen masses for three or four-wheel motor vehicles are as follows:  3.2.2.1. three-wheel motor vehicles:  270 kg for mopeds;  1 000 kg for tricycles (no account is taken of the mass of traction batteries for electric vehicles);  3.2.2.2. four-wheel motor vehicles:  350 kg - light quadricycles;  400 kg - quadricycles other than light for transport of persons;  550 kg - quadricycles other than light for transport of goods (no account is taken of the mass of traction batteries for electric vehicles).  3.2.3. The maximum payloads declared by the manufacturer for three or four-wheel motor vehicles are as follows:  3.2.3.1. three-wheel mopeds:  300 kg;  3.2.3.2. light quadricycles:  200 kg;  3.2.3.3. tricycles:  3.2.3.3.1. for transport of goods:  1 500 kg;  3.2.3.3.2. for transport of persons:  300 kg;  3.2.3.4. quadricycles, other than light:  3.2.3.4.1. for transport of goods:  1 000 kg;  3.2.3.4.2. for transport of persons:  200 kg;  3.2.4. two, three or four-wheel motor vehicles can be authorized to tow a mass declared by the manufacturer not exceeding 50 % of the unladen mass of the vehicle.   Appendix 1  Information document in respect of the masses and dimensions of a type of two or three-wheel motor vehicle (to be attached to the application for component type-approval where this is submitted separately from the application for vehicle type-approval) Order No (assigned by the applicant):  .  The application for component type-approval in respect of the masses and dimensions of a type of two or three-wheel motor vehicle must contain the information set out Annex II to Directive 92/61/EEC:  - under Part A, sections:  - 0.1,  - 0.2,  - 0.4 to 0.6,  - 1.2,  - 2.1 to 2.5,  - under Part C, section 1.2.1.   Appendix 2  Name of administration Component type-approval certificate in respect of the masses and dimensions of a type of two or three-wheel motor vehicle MODEL Report No . by technical service . date .  Component type-approval No .Extension No .  1. Trade mark or name of vehicle: .  2. Type of vehicle: .  3. Manufacturer's name and address: .   .  4. Name and address of manufacturer's representative (if any): .   .  5. Date vehicle submitted for test: .  6. Component type-approval granted/refused(1) .  7. Place: .  8. Date: .  9. Signature .   (1) Delete as appropriate.


Avis juridique important

|

31988L0233

Tenth Commission Directive 88/233/EEC of 2 March 1988 adapting to technical progress Annexes II, III, IV and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products

Official Journal L 105 , 26/04/1988 P. 0011 - 0014 Finnish special edition: Chapter 13 Volume 17 P. 0058  Swedish special edition: Chapter 13 Volume 17 P. 0058

*****TENTH  COMMISSION DIRECTIVE  of 2 March 1988  adapting to technical progress Annexes II, III, IV and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products  (88/233/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), as last amended by Directive 87/137/EEC (2), and in particular Article 8 (2) thereof,  Whereas, on the basis of the information now available, certain provisionally permitted colouring agents, substances or preservatives may be definitively permitted, while others must be definitively prohibited or be permitted for a further specific period;  Whereas, with a view to the protection of public health, it is necessary to prohibit the use of 3,4,5-tribromosalicylanilide, Phytolacca spp. and their preparations, retinoic acid and certain hair-dyeing substances;  Whereas, with a view to the protection of public health, it is necessary to adopt provisions concerning the instruction for use and the compulsory label warnings of cosmetic products containing thioglycollic acid, its salts and esters;  Whereas, on the basis of the information available, it is necessary to extend the field of application of quinolin-8-ol and bis (8-hydroxyquinolium) sulphate:  Whereas, in the light of the results of the most recent scientific and technical research, the use of etidronic acid and its salts for hair care and in specific soaps may be authorized under certain conditions;  Whereas it is necessary to prohibit the other uses of the preservative chlorphenesin;  Whereas the measures provided for by this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Removal of Technical Barriers to Trade in the Cosmetics Sector,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 76/768/EEC is hereby amended as follows:  1. In Annex II:  - delete 'except as impurities of tribromosalicylanilide in accordance with the criteria laid down in Annex IV (Part 1)' in 350 and 351;  - delete 'except as an impurity of hexachlorophene under the conditions provided for in Annex VI, Part 1, point 6' in 367;  - add the following numbers:  '373. 3,4,5-Tribromosalicylanide (tribromsalan)  374. Phytolacca spp. and their preparations  375. Tretinoin* (retinoic acid and its salts)  376. 1-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole - CI 76050)  377. 1-Methoxy-2,5-diaminobenzene (2,5-diaminoanisole)  378. Colouring agent CI 12140  379. Colouring agent CI 26105  380. Colouring agent CI 42555  Colouring agent CI 42555-1  Colouring agent CI 42555-2'  2. In Annex III, Part 1:  - replace Nos 2 and 51 by:  1.2.3.4.5.6 //  //  //  //  //  //  // a  // b  // c  // d  // e  // f  //  //  //  //  //  // 1.2.3.4 // '2a  // Thioglycollic acid and its salts   // (a) Hair waving or straightening products:   //   //   //   // - general use  // - 8 % ready for use pH 7 to 9,5   //   //   // - professional use   // - 11 % ready for use pH 7 to 9,5   //  //   // (b) Depilatories   // - 5 % ready for use pH 7 to 12,7   //   //   // (c) Other hair-care products which are removed after application   // - 2 % ready for use pH to 9,5 The abovementioned percentages are calculated as thioglycollic acid  1.2 // (a) (b) (c): The directions for use drawn up in the national or official language(s) must obligatorily incorporate the following sentences: - Avoid contact with eyes - In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice - Wear suitable gloves (a) and (c) only)   // (a): - Contains thioglycolate - Follow the instructions - Keep out of reach of children - For professional use only (b) and (c): - Contains thioglycolate - Follow the instructions - Keep out of reach of children  1.2.3.4 // 2b  // Thioglycollic acid esters   // Hair waving or straightening products:   //   //   //   // - general use   // - 8 % ready for use pH 6 to 9,5   //   //   // - professional use   // - 11 % ready for use pH 6 to 9,5   //   //   //   // The abovementioned percentages are calculated as thioglycollic acid  1.2 // The directions for use drawn up in the national or official language(s) must obligatorily incorporate the following sentences: - May cause sensitization in the event of skin contact - Avoid contact with eyes - In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice - Wear suitable gloves   // - Contains thioglycolate - Follow the instructions - Keep out of reach of children - For professional use only'  1.2.3.4.5.6 //    //  //   //   //   //   // '51   // Quinolin-8-ol and bis (8-hydroxy-quinolium) sulphate   // Stabilizer for hydrogen peroxide in rinse-off hair-care preparations   // 0,3 % calculated as base   //   //   //   //   // Stabilizer for hydrogen peroxide in non-rinse-off hair-care prepar-  ations  // 0,03 % calculated as base'   //   //   //    //   //   //  //   //  - add Nos 53 and 54:  1.2.3.4.5.6 //  //  //  //  //  //  // a  // b  // c  // d  // e  // f  //  //  //  //  //  // 1.2.3.4.5.6.7 // '53  // Etidronic acid and its salts (1-hy- droxyethylidene- di-phosphonic acid and its salts)   // (a) Hair-care (b) Soap  // 1,5 % 0,2 %   // expressed as etidronic acid   //  // Contains etidronic acid   //    //   //   //   //   //  //   // 54   // 1-Phenoxy-propan- 2-ol   // - Rinse-off products only - Prohibited in oral hygiene products   // 2 %  //   // As a preservative, see Annex VI, Part 1, No 43'   //  //    //   //   //   //   //   //  3. In Annex III, Part 2:  (a) add the colouring agent Acid Red 195, together with:  - colour: red,  - field of application: 3;  (b) delete 13065  4. Annex IV, Part 1 is hereby amended as follows:  (a) replace '31. 12. 1987' by '31. 12. 1989' in column (g) for the following numbers:  - No 2, 1,1,1-trichloroethane,  - No 4, 2,2dithiobis (pyridine 1-oxide), addition product with magnesium sulphate trihydrate;  (b) delete Nos 3 and 5 - 3,4,5-tribromosalicylanilide and 1-phenoxypropan-2-ol  5. In Annex IV, Part 2:  (a) delete Nos 12700, 44025, 73312 and Acid Red 195;  (b) replace '31. 12. 1987' by '31. 12. 1988' in the 'Authorization valid until' column in the case of Nos 13065, 21110, 42535, 44045, 61554 and 73900;  (c) delete the wording in the 'Other limitations and requirements' column in the case of No 13065;  6. In Annex VI - Part One:  (a) add the following numbers:  1.2.3.4.5 //  //  //  //  //  // a  // b  // c  // d  // e  //  //  //  //  //  // '41   // 2-Chloroacetamide   // 0,3 %  //   // Contains chloro- acetamide   //    //   //   //   //  // 42   // Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride (+)   // 0,3 % expressed as chlorhexidine  //   //   //    //   //   //   //   // 43  // 1-Phenoxypropan-2-ol   // 1,0   // Only for rinse-off products'   //   //    //   //   //   //  (b) delete the wording in column (d) in the case of substance No 19;  7. In Annex VI, Part 2:  (a) delete the following numbers:  7. 5-Bromo-5-nitro-1,3-dioxane,  8. Undec-10-enoic acid: esters, the amide, the mono- and bis (2-hydroxethyl) amides and their sulphosuccinates (+),  10. 2-Chloro-N (hydroxymethyl) acetamide,  11. Pyrithione aluminium camsilate (INNM),  14. 1-Phenoxypropan-2-ol, 18. Hexetidine (INN) (+),  22. 2-Chloroacetamide,  23. 1-Dodecylguanidinium acetate (dodine - ISO) (+),  24. Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride (+);  (b) in the case of No 2, chlorphenesin, delete the symbol (+) in column (b), replace 0,5 % by 0,3 % for the concentration value in column (c) and replace '31. 12. 1987' by '31. 12. 1989' in column (f);  (c) replace '31. 12. 1987' by '31. 12. 1988' in column (f) in the case of the following number:  16. Benzalkonium chloride (INN), bromide and saccharinate (+);  (d) replace '31. 12. 1987' by '31. 12. 1989' in column (f) in the case of No 17, 1-[1,3-bis (hydroxymethyl)2,5-dioxoimidazolidin-1-yl]-1,3-bis (hydroxymethyl) urea;  (e) in the case of No 21, benzylformal, replace the name in column (b) by Benzylhemiformal and replace '31. 12. 1987' by '31. 12. 1989' in column (f).  Article 2  1. Without prejudice to the authorization dates referred to in Article 1 (4), (5) and (7), Member States shall take the necessary measures to ensure that, from 1 January 1989 in the case of the substances referred to in Article 1 (1), and from 1 January 1990 in the case of the substances referred to in Article 1 (2), (3), (6) and (7), neither manufacturers nor importers established in the Community place on the market products which do not satisfy the requirements of this Directive.  2. Member States shall take the necessary measures to ensure that the products referred to in paragraph 1 containing the substances referred to in Article 1 (1) and the substances referred to in Article 1 (2), (3), (6) and (7) can no longer be sold or disposed of to the final consumer after 31 December 1989 and 31 December 1991, respectively.  Article 3  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive not later than 30 September 1988. They shall forthwith inform the Commission thereof.  2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by its Directive.  Article 4  This Directive is addressed to the Member States.  Done at Brussels, 2 March 1988.  For the Commission  Grigoris VARFIS  Member of the Commission  (1) OJ No L 262, 27. 9. 1976, p. 169.  (2) OJ No L 56, 26. 2. 1987, p. 20.


Avis juridique important

|

31994L0015

Commission Directive 94/15/EC of 15 April 1994 adapting to technical progress for the first time Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms

Official Journal L 103 , 22/04/1994 P. 0020 - 0027

COMMISSION DIRECTIVE 94/15/EC of 15 April 1994 adapting to technical progress for the first time Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organismsTHE COMMISSION OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Community,  Having regard to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (1), and in particular Article 20 thereof,  Whereas Annex II to Directive 90/220/EEC contains the information required to be provided in a notification for a deliberate release of genetically modified organisms (GMOs);  Whereas the information requirements for notifications for a deliberate release of GMOs, as set out in Annex II, are very broad in order to apply to all types of GMOs; whereas some of the information is only applicable or appropriate for specific types  of organisms;  Whereas, on the basis of the experience gained with the releases of genetically modified higher plants, it is appropriate to adapt Annex II to technical progress by making provision for a sub-Annex specific to higher plants;  Whereas it is therefore appropriate that Annex II should be divided in two sub-Annexes: Annex II A outlining the information required in the notifications concerning releases of GMOs other than higher plants, and Annex II B outlining the information  required in the notifications concerning releases of genetically modified higher plants;  Whereas the measures provided for in this Directive are in accordance with the opinion of the committee provided for in Article 21 of Directive 90/220/EEC,  HAS ADOPTED THIS DIRECTIVE:   Article 1  Annex II to Directive 90/220/EEC is replaced by the Annex hereto.   Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 1994. They shall immediately 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.   Article 3  This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.  Done at Brussels, 15 April 1994.  For the Commission Yannis PALEOKRASSAS Member of the Commission  (1) OJ No L 117, 8. 5. 1990, p. 15.      ANNEX  'ANNEX II INFORMATION REQUIRED IN THE NOTIFICATION The notification for a deliberate release referred to in Article 5 and of the placing on the market referred to in Article 11 is to include, as appropriate, the information set out below in the sub-Annexes.  Not all points included will apply to every case. It is to be expected that individual notifications will address only the particular subset of considerations which is appropriate to individual situations.  The level of detail required in response to each subset of considerations is also likely to vary according to the nature and scale of the proposed release.  Annex II A applies to releases of all types of genetically modified organisms other than higher plants. Annex II B applies to releases of genetically modified higher plants.  The term "higher plants" means plants which belong to the taxonomic groups Gymnospermae and Angiospermae.  ANNEX II A INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER PLANTS I. GENERAL INFORMATION A. Name and address of the notifier (company or institute) B. Name, qualifications and experience of the responsible scientist(s) C. Title of the project II. INFORMATION RELATING TO THE GMO A. Characteristics of (a) the donor, (b) the recipient or (c) (where appropriate) parental organism(s):  1. scientific name;  2. taxonomy;  3. other names (usual name, strain name, etc.);  4. phenotypic and genetic markers;  5. degree of relatedness between donor and recipient or between parental organisms;  6. description of identification and detection techniques;  7. sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques;  8. description of the geographic distribution and of the natural habitat of the organism including information on natural predators, preys, parasites and competitors, symbionts and hosts;  9. potential for genetic transfer and exchange with other organisms;  10. verification of the genetic stability of the organisms and factors affecting it;  11. pathological, ecological and physiological traits:  (a) classification of hazard according to existing Community rules concerning the protection of human health and/or the environment;  (b) generation time in natural ecosystems, sexual and asexual reproductive cycle;  (c) information on survival, including seasonability and the ability to form survival structures e.g.: seeds, spores or sclerotia;  (d) pathogenicity: infectivity, toxigenicity, virulence, allergenicity, carrier (vector) of pathogen, possible vectors, host range including non-target organism. Possible activation of latent viruses (proviruses). Ability to colonize other organisms;  (e) antibiotic resistance, and potential use of these antibiotics in humans and domestic organisms for prophylaxis and therapy;  (f) involvement in environmental processes: primary production, nutrient turnover, decomposition of organic matter, respiration, etc.  12. Nature of indigenous vectors:  (a) sequence;  (b) frequency of mobilization;  (c) specificity;  (d) presence of genes which confer resistance.  13. History of previous genetic modifications.  B. Characteristics of the vector:  1. nature and source of the vector;  2. sequence of transposons, vectors and other non-coding genetic segments used to construct the GMO and to make the introduced vector and insert function in the GMO;  3. frequency of mobilization of inserted vector and/or genetic transfer capabilities and methods of determination;  4. information on the degree to which the vector is limited to the DNA required to perform the intended function.  C. Characteristics of the modified organism:  1. Information relating to the genetic modification:  (a) methods used for the modification;  (b) methods used to construct and introduce the insert(s) into the recipient or to delete a sequence;  (c) description of the insert and/or vector construction;  (d) purity of the insert from any unknown sequence and information on the degree to which the inserted sequence is limited to the DNA required to perform the intended function;  (e) sequence, functional identity and location of the altered/inserted/deleted nucleic acid segment(s) in question with particular reference to any known harmful sequence.  2. Information on the final GMO:  (a) description of genetic trait(s) or phenotypic characteristics and in particular any new traits and characteristics which may be expressed or no longer expressed;  (b) structure and amount of any vector and/or donor nucleic acid remaining in the final construction of the modified organism;  (c) stability of the organism in terms of genetic traits;  (d) rate and level of expression of the new genetic material. Method and sensitivity of measurement;  (e) activity of the expressed protein(s);  (f) description of identification and detection techniques including techniques for the identification and detection of the inserted sequence and vector;  (g) sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques;  (h) history of previous releases or uses of the GMO;  (i) health considerations:  (i) toxic or allergenic effects of the non-viable GMOs and/or their metabolic products;  (ii) product hazards;  (iii) comparison of the modified organism to the donor, recipient or (where appropriate) parental organism regarding pathogenicity;  (iv) capacity for colonization;  (v) if the organism is pathogenic to humans who are immunocompetent:  - diseases caused and mechanism of pathogenicity including invasiveness and virulence,  - communicability,  - infective dose,  - host range, possibility of alteration,  - possibility of survival outside of human host,  - presence of vectors or means of dissemination,  - biological stability,  - antibiotic-resistance patterns,  - allergenicity,  - availability of appropriate therapies.  III. INFORMATION RELATING TO THE CONDITIONS OF RELEASE AND THE RECEIVING ENVIRONMENT A. Information on the release:  1. description of the proposed deliberate release, including the purpose(s) and foreseen products;  2. foreseen dates of the release and time planning of the experiment including frequency and duration of releases;  3. preparation of the site previous to the release;  4. size of the site;  5. method(s) to be used for the release;  6. quantities of GMOs to be released;  7. disturbance on the site (type and method of cultivation, mining, irrigation, or other activities);  8. worker protection measures taken during the release;  9. post-release treatment of the site;  10. techniques foreseen for elimination or inactivition of the GMOs at the end of the experiment;  11. information on, and results of, previous releases of the GMOs, especially at different scales and in different ecosystems.  B. Information on the environment (both on the site and in the wider environment):  1. geographical location and grid reference of the site(s) (in case of notifications under Part C the site(s) of release will be the foreseen areas of use of the product);  2. physical or biological proximity to humans and other significant biota;  3. proximity to significant biotopes or protected areas;  4. size of local population;  5. economic activities of local populations which are based on the natural resources of the area;  6. distance to closest areas protected for drinking water and/or environmental purpose;  7. climatic characteristics of the region(s) likely to be affected;  8. geographical, geological and pedological characteristics;  9. flora and fauna, including crops, livestock and migratory species;  10. description of target and non-target ecosystems likely to be affected;  11. a comparison of the natural habitat of the recipient organism with the proposed site(s) of release;  12. any known planned developments or changes in land use in the region which could influence the environmental impact of the release.  IV. INFORMATION RELATING TO THE INTERACTIONS BETWEEN THE GMOs AND THE ENVIRONMENT A. Characteristics affecting survival, multiplication and dissemination:  1. biological features which affect survival, multiplication and dispersal;  2. known or predicted environmental conditions which may affect survival, multiplication and dissemination (wind, water, soil, temperature, pH, etc.);  3. sensitivity to specific agents.  B. Interactions with the environment:  1. predicted habitat of the GMOs;  2. studies of the behaviour and characteristics of the GMOs and their ecological impact carried out in simulated natural environments, such as microcosms, growth rooms, greenhouses;  3. genetic transfer capability:  (a) post-release transfer of genetic material from GMOs into organisms in affected ecosystems;  (b) post-release transfer of genetic material from indigenous organisms to the GMOs;  4. likelihood of post-release selection leading to the expression of unexpected and/or undesirable traits in the modified organism;  5. measures employed to ensure and to verify genetic stability. Description of genetic traits which may prevent or minimize dispersal of genetic material. Methods to verify genetic stability;  6. routes of biological dispersal, known or potential modes of interaction with the disseminating agent, including inhalation, ingestion, surface contact, burrowing, etc.;  7. description of ecosystems to which the GMOs could be disseminated.  C. Potential environmental impact:  1. potential for excessive population increase in the environment;  2. competitive advantage of the GMOs in relation to the unmodified recipient or parental organism(s);  3. identification and description of the target organisms;  4. anticipated mechanism and result of interaction between the released GMOs and the target organism;  5. identification and description of non-target organisms which may be affected unwittingly;  6. likelihood of post-release shifts in biological interactions or in host range;  7. known or predicted effects on non-target organisms in the environment, impact on population levels of competitors: preys, hosts, symbionts, predators, parasites and pathogens;  8. known or predicted involvement in biogeochemical processes;  9. other potentially significant interactions with the environment.  V. INFORMATION ON MONITORING, CONTROL, WASTE TREATMENT AND EMERGENCY RESPONSE PLANS A. Monitoring techniques:  1. methods for tracing the GMOs, and for monitoring their effects;  2. specificity (to identify the GMOs, and to distinguish them from the donor, recipient or, where appropriate, the parental organisms), sensitivity and reliability of the monitoring techniques;  3. techniques for detecting transfer of the donated genetic material to other organisms;  4. duration and frequency of the monitoring.  B. Control of the release:  1. methods and procedures to avoid and/or minimize the spread of the GMOs beyond the site of release or the designated area for use;  2. methods and procedures to protect the site from intrusion by unauthorized individuals;  3. methods and procedures to prevent other organisms from entering the site.  C. Waste treatment:  1. type of waste generated;  2. expected amount of waste;  3. possible risks;  4. description of treatment envisaged.  D. Emergency response plans:  1. methods and procedures for controlling the GMOs in case of unexpected spread;  2. methods for decontamination of the areas affected, e.g. eradication of the GMOs;  3. methods for disposal or sanitation of plants, animals, etc., that were exposed during or after the spread;  4. methods for the isolation of the area affected by the spread;  5. plans for protecting human health and the environment in case of the occurrence of an undesirable effect.  ANNEX II B INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED HIGHER PLANTS (GMHPs) (GYMNOSPERMAE AND ANGIOSPERMAE) A. GENERAL INFORMATION 1. Name and address of the notifier (company or institute) 2. Name, qualifications and experience of the responsible scientist(s) 3. Title of the project B. INFORMATION RELATING TO (A) THE RECIPIENT OR (B) (WHERE APPROPRIATE) PARENTAL PLANTS 1. Complete name:  (a) family name;  (b) genus;  (c) species;  (d) subspecies;  (e) cultivar/breeding line;  (f) common name.  2. (a) Information concerning reproduction:  (i) mode(s) of reproduction;  (ii) specific factors affecting reproduction, if any;  (iii) generation time.  (b) Sexual compatibility with other cultivated or wild plant species.  3. Survivability:  (a) ability to form structures for survival or dormancy;  (b) specific factors affecting survivability, if any.  4. Dissemination:  (a) ways and extent of dissemination;  (b) specific factors affecting dissemination, if any.  5. Geographical distribution of the plant.  6. In the case of plant species not normally grown in the Member State(s), description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.  7. Potentially significant interactions of the plant with organisms other than plants in the ecosystem where it is usually grown, including information on toxic effects on humans, animals and other organisms.  C. INFORMATION RELATING TO THE GENETIC MODIFICATION 1. Description of the methods used for the genetic modification.  2. Nature and source of the vector used.  3. Size, source (name of donor organism(s) and intended function of each constituent fragment of the region intended for insertion.  D. INFORMATION RELATING TO THE GENETICALLY MODIFIED PLANT 1. Description of the trait(s) and characteristics which have been introduced or modified.  2. Information on the sequences actually inserted/deleted:  (a) size and structure of the insert and methods used for its characterization, including information on any parts of the vector introduced in the GMHP or any carrier or foreign DNA remaining in the GMHP;  (b) in case of deletion, size and function of the deleted region(s);  (c) location of the insert in the plant cells (integrated in the chromosome, chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its determination;  (d) copy number of the insert.  3. Information on the expression of the insert:  (a) information on the expression of the insert and methods used for its characterization;  (b) parts of the plant where the insert is expressed (e.g. roots, stem, pollen etc.).  4. Information on how the genetically modified plant differs from the recipient plant in:  (a) mode(s) and/or rate of reproduction;  (b) dissemination;  (c) survivability.  5. Genetic stability of the insert.  6. Potential for transfer of genetic material from the genetically modified plants to other organisms.  7. Information on any toxic or harmful effects on human health and the environment, arising from the genetic modification.  8. Mechanism of interaction between the genetically modified plant and target organisms (if applicable).  9. Potentially significant interactions with non-target organisms.  10. Description of detection and identification techniques for the genetically modified plant.  11. Information about previous releases of the genetically modified plant, if applicable.  E. INFORMATION RELATING TO THE SITE OF RELEASE (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLE 5) 1. Location and size of the release site(s).  2. Description of the release site ecosystem, including climate, flora and fauna.  3. Presence of sexually compatible wild relatives or cultivated plant species.  4. Proximity to officially recognized biotopes or protected areas which may be affected.  F. INFORMATION RELATING TO THE RELEASE (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLE 5) 1. Purpose of the release.  2. Foreseen date(s) and duration of the release.  3. Method by which the genetically modified plants will be released.  4. Method for preparing and managing the release site, prior to, during and post-release, including cultivation practices and harvesting methods.  5. Approximate number of plants (or plants per m2).  G. INFORMATION ON CONTROL, MONITORING, POST-RELEASE AND WASTE TREATMENT PLANS (ONLY FOR NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLE 5) 1. Any precautions taken:  (a) distance(s) from sexually compatible plant species;  (b) any measures to minimize/prevent pollen or seed dispersal.  2. Description of methods for post-release treatment of the site.  3. Description of post-release treatment methods for the genetically modified plant material including wastes.  4. Description of monitoring plans and techniques.  5. Description of any emergency plans. H. INFORMATION ON THE POTENTIAL ENVIRONMENTAL IMPACT FROM THE RELEASE OF THE GENETICALLY MODIFIED PLANTS 1. Likelihood of the GMHP becoming more persistent than the recipient or parental plants in agricultural habitats or more invasive in natural habitats.  2. Any selective advantage or disadvantage conferred to other sexually compatible plants species, which may result from genetic transfer from the genetically modified plant.  3. Potential environmental impact of the interaction between the genetically modified plant and target organisms (if applicable).  4. Possible environmental impact resulting from potential interactions with non-target organisms.'