Avis juridique important

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31995L0036

Commission Directive 95/36/EC of 14 July 1995 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market

Official Journal L 172 , 22/07/1995 P. 0008 - 0020

COMMISSION DIRECTIVE 95/36/EC of 14 July 1995 amending Council Directive 91/414/EEC concerning the  placing of plant protection products on the market (Text with EEA relevance)THE  COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant  protection products on the market  (1), as last amended by Commission Directive 95/35/EC  (2), and  in particular Article 18 (2) thereof, Whereas Annexes II and III to Directive 91/414/EEC provide the requirements for the dossier to be  submitted by applicants respectively for the inclusion of an active substance in Annex I and for  the authorization of a plant protection product; Whereas it is necessary to indicate, in Annexes II and III to Directive 91/414/EEC, to the  applicants as precisely as possible any details on the required information, such as the  circumstances, conditions and technical protocols under which certain data have to be generated;  whereas these provisions should be introduced as soon as available in order to permit applicants to  use them in the preparation of their files; Whereas it is possible to introduce now more precision with regard to the data requirements  concerning fate and behaviour in the environment of the active substance provided for in Annex II,  Part A, Section 7; Whereas it is also possible to introduce now more precision with regard to the data requirements  concerning fate and behaviour in the environment of the plant protection product provided for in  Section 9 of Part A of Annex III, Part A, Section 9; Whereas the measures provided for in this Directive are in accordance with the opinion of the  Standing Committee on Plant Health, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 91/414/EEC is amended as follows: 1.  in Part A of Annex II, the section headed '7. Fate and behaviour in the environment` is  replaced by Annex I hereto; 2.  in Part A of Annex III, the section headed '9. Fate and behaviour in the environment` is  replaced by Annex II hereto. Article 2 Member States shall bring into force the laws, regulations and administrative  provisions necessary to comply, not later than 30 April 1996, with the provisions of this  Directive. They shall immediately inform the Commission thereof. When Member States adopt these measures, 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 the Member States. Article 3 This Directive shall enter into force on 1 July 1995. Article 4 This Directive is addressed to the Member States. Done at Brussels, 14 July 1995. For the Commission Ritt BJERREGAARD Member of the Commission  ANNEX I '7. FATE AND BEHAVIOUR IN THE ENVIRONMENT Introduction (i)  The information provided, taken together with that for one or more preparations containing the  active substance, must be sufficient to pemit an assessment of the fate and behaviour of the active  substance in the environment, and of the non-target species likely to be at risk from exposure to  the active substance, its metabolites, degradation and reaction products, where they are of  toxicological or environmental significance. (ii)  In particular, the information provided for the active substance, together with other  relevant information, and that provided for one or more preparations containing it, should be  sufficient to: -  decide whether, or not, the active substance can be included in Annex I, -  specify appropriate conditions or restrictions to be associated with any inclusion in Annex I, -  classify the active substance as to hazard; -  specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for  the protection of the environment, which are to be included on packaging (containers), -  predict the disribution, fate, and behaviour in the environment of the active substance and  relevant metabolites, degradation and reaction products as well as the times courses involved, -  identify non-target species and populations for which hazards a rise because of potential  exposure, and -  identify measures necesary to minimize contamination of the environment and impact on non-target  species. (iii)  A detailed description (specification) of the material used, as provided for under Section  1, point 11 must be provided. Where testing is done using active substance the material used should  be of that specification that will be used in the manufacture of preparations to be authorized  except where radio-labelled material is used. Where studies are conducted using active substance produced in the laboratory or in a pilot plant  production system, the studies must be repeated using active substance as manufactured, unless it  can be justified that the test material used is essentially the same for the purposes of  environmental testing and assessment. (iv)  Where radio-labelled test material is used, radio-labels should be positioned at sites (one  or more as necessary), to facilitate elucidation of metabolic and degradative pathways and to  facilitate investigation of the distribution of the active substance and of its metabolite,  reaction and degradation products in the environment. (v)  It may be necessary to conduct separate studies for metabolites, degradation or reaction  products, where these products can constitute a relevant risk to non-target organisms or to the  quality of water, soil and air and where their effects cannot be evaluated by the available results  relating to the active substance. Before such studies are performed the information from the  Sections 5 and 6 has to be taken into account. (vi)  Where relevant, tests should be designed and data analysed using appropriate statistical  methods. Full details of the statistical anaylsis should be reported (e.g. all point estimates should be  given with confidence intervals, exact p-values should be given rather than stating significant/non  significant). 7.1. Fate and behaviour in soil All relevant information on the type and the properties of the soil used in the studies, including  pH, organic carbon content, cation exchange capacity, particle size distribution and water holding  capacity, particle size distribution and water holding capacity at pF=0 and pF=2,5 has to be  reported in accordance with relevant ISO or other international standards. The microbial biomass of soils used for laboratory degradation studies must be determined just  prior to the commencement and at the end of the study. It is recommended to use as much as possible the same soils throughout all laboratory soil  studies. The soils used for degradation or mobility studies must be selected such that they are  representative of the range of soils typical of the various Community regions where use exists or  is anticipated, and be such that: -  they cover a range of organic carbon content, particle size distribution and pH values; and -  where on the basis of other information, degradation or mobility are expected to be pH dependent  (e.g. solubility and hydrolysis rate - paragraphs 2.7 and 2.8), they cover the following pH  ranges: -  4,5 to 5,5 -  6 to 7, and -  8 (approximately). Soils used must, wherever possible, be freshly sampled. If use of stored soils is unavoidable,  storage should be properly carried out for a limited time under defined and reported conditions.  Soils stored for longer periods of time can only be used for adsorption/desorption studies. The soil chosen to begin studying should not have extreme characteristics with respect to  parameters such as particle size distribution, organic carbon content and pH. Soils should be collected and handled in accordance with ISO 10381-6 (Soil quality - Sampling -  Guidance on the collection, handling and storage of soil for the assessment of microbial processes  in the laboratory). Any deviations must be reported and justified. Field studies should be carried out in conditions as close to normal agricultural practice as  possible on a range of soil types and climatic conditions representative of the area(s) of use.  Weather conditions shall be reported in cases where field studies are conducted. 7.1.1. Route and rate of degradation 7.1.1.1. Route of degradation Aim of the tests The data and information provided, together with other relevant data and information, should be  sufficient to: -  identify, where feasable, the relative importance of the types of process involved (balance  between chemical and biological degradation), -  identify the individual components present which at any time account for more than 10  % of the  amount of active substance added, including, where feasible, non-extractable residues, -  identify where possible also individual components present which account for less than 10  % of  the amount of active substance added, -  establish the relative proportions of the components present (mass balance), and -  permit the soil residue of concern and to which non-target species are or may be exposed, to be  defined. Where a reference is made to non-extractable residues these are defined as chemical species  originating from pesticides used according to good agricultural practice that cannot be extracted  by methods which do not significantly change the chemical nature of these residues. These  non-extractable residues are not considered to include fragments through metabolic pathways leading  to natural products. 7.1.1.1.1. Aerobic degradation Circumstances in which required The degradation pathway or pathways must always be reported except where the nature and manner of  use of preparations containing the active substance, preclude soil contamination such as uses on  stored products or wound healing treatments for trees. Test conditions The degradation pathway or pathways must be reported for one soil. Results obtained must be presented in the form of schematic drawings showing the pathways involved,  and in the form of balance sheets which show the distribution of radio-label as a function of time,  as between: -  active substance, -  CO2, -  volatile compounds other than CO2, -  individual identified transformation products, -  extractable substances not identified, and -  non-extractable residues in soil. The investigation of degradation pathways must include all feasible steps to characterise and  quantify non-extractable residues formed after 100 days when exceeding 70  % of the applied dose of  the active substance. The techniques and methodologies applied are best selected on a case-by-case  basis. A justification must be provided where the compounds involved are not characterized. The duration of the study is normally 120 days, except where after a shorter period the levels of  non-extractable residues and CO2 are such that they can be extrapolated in a reliable way to 100  days. Test guideline Setac - Procedures for assessing the environmental fate and ecotoxicity of pesticides  (1). 7.1.1.1.2. Supplementary studies -  Anaerobic degradation Circumstances in which required An anaerobic degradation study must be reported unless it can be justified that exposure of the  plant protection products containing the active substance to anaerobic conditions is unlikely to  occur. Test conditions and test guideline The same provisions as provided for under the corresponding paragraph of point 7.1.1.1.1 apply. -  Soil photolysis Circumstances in which required A soil photolysis study must be reported unless it can be justified that deposition of the active  substance at the soil surface is unlikely to occur. Test guideline Setac - Procedures for assessing the Environmental fate and ecotoxicity of pesticides. 7.1.1.2. Rate of degradation 7.1.1.2.1. Laboratory studies Aim of the tests The soil degradation studies should provide best possible estimates of the time taken for  degradation of 50  % and 90  % (DT50lab and DT90lab), of the active substance, and of relevant  metabolites, degradation and reaction products under laboratory conditions. -  Aerobic degradation Circumstances in which required The rate of degradation in soil must always be reported, except where the nature and manner of use  of plant protection products containing the active substance preclude soil contamination such as  uses on stored products or wound healing treatments for trees. Test conditions The rate of aerobic degradation of the active substance in three soil types additional to that  referred to in paragraph 7.1.1.1.1. must be reported. In order to investigate the influence of temperature on degradation, one additional study at 10  °C  has to be performed on one of the soils used for the investigation of degradation at 20  °C until a  validated Community calculation model for the extrapolation of degradation rates at low  temperatures is available. The duration of the study is normally 120 days except if more than 90  % of the active substance is  degraded before that period expires. Similar studies for three soil types must be reported for all relevant metabolites, degradation and  reaction products which occur in soil and which at any time during the studies account for more  than 10  % of the amount of active substance added, except where their DT50 values were able to be  determined from the results of the degradation studies with the active substance. Test guideline Setac - Procedures for assessing the environmental fate and ecotoxicity of pesticides. -  Anaerobic degradation Circumstances in which required The rate of anaerobic degradation of the active substance must be reported where an anaerobic study  has to be performed according to point 7.1.1.1.2. Test conditions The rate of anaerobic degradation of the active substance must be carried out in the soil used in  the anaerobic study performed according to point 7.1.1.1.2. The duration of the study is normally 120 days except if more than 90  % of the active substance is  degraded before that period expires. Similar studies for one soil must be reported for all relevant metobolites, degradation and  reaction products which occur in soil and which at any time during the studies account for more  than 10  % of the amount of active substance added, except where their DT50 values were able to be  determined from the results of the degradation studies with the active substance. Test guideline Setac - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 7.1.1.2.2. Field studies -  Soil dissipation studies Aim of the test The soil dissipation studies should provide estimates of the time taken for dissipation of 50  %  and 90  % (DT50f and DT90f), of the active substance under field conditions. Where relevant,  information on relevant metabolites, degradation and reaction products must be reported. Circumstances in which required Where plant protection products containing the active substance are intended to be used in cold  climatic conditions, the tests have to be conducted where DT50lab, determined at 10  °C and at a  moisture content of the soil related to a pF value of 2 to 2,5 (suction pressure) is greater than  90 days. Test conditions Individual studies on a range of representative soils (normally four different types) must be  continued until > 90  % of the amount applied have dissipated. The maximum duration of the studies  is 24 months. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. -  Soil residue studies Aim of the test Soil residue studies should provide estimates of the soil residue levels at harvest or at time of  cowing or planting succeeding crops. Circumstances in which required Soil residue studies must be reported where DT50lab is greater than one-third of the period between  the application and harvest and where absorption by the succeeding crop is possible, except where  soil residues at sowing or planting of a succeeding crop can be reliably estimated from the data of  the soil dissipation studies or where it can be justified that these residues can not be phytotoxic  to or leave unacceptable residues in rotational crops. Test conditions Individual studies must be continued until harvest or time of sowing or planting succeeding crops,  unless > 90  % of the amount applied have dissipated. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. -  Soil accumulation studies Aim of the tests The tests should provide sufficient data to evaluate the possibility of accumulation of residues of  the active substance and of relevant metabolites, degradation and reaction products. Circumstances in which required Where on the basis of soil dissipation studies it is established that DT90f > one year and where  repeated application is envisaged, whether in the same growing season or in succeeding years, the  possibility of accumulation of residues in soil and the level at which a plateau concentration is  achieved must be investigated except where reliable information can be provided by a model  calculation or another appropriate assessment. Test conditions Long term field studies must be done on two relevant soils and involve multiple applications. Before performing these studies the applicant shall seek the agreement of the competent authorities  on the type of study to be performed. 7.1.2. Adsorption and desorption Aim of the test The data and information provided, together with other relevant data and information, should be  sufficient to establish the absorption coefficient of the active substance and of relevant  metabolites, degradation and reaction products. Circumstances in which required The studies must always be reported except where the nature and manner of use of preparations  containing the active substance, preclude soil contamination such as uses on stored products or  wound healing trees. Testo conditions Studies on the active substance must be reported for four soil types. Similar studies, for at least three soil types, must be reported for all relevant metabolites,  degradation and reaction products which in soil degradation studies account at any time for more  than 10  % of the amount of active substance added. Test guideline OECD method 106 7.1.3. Mobility in the soil 7.1.3.1. Column leaching studies Aim of the test The test should provide sufficient data to evaluate the mobility and leaching potential of the  active substance and if possible of relevant metabolities, degradation and reaction products. Circumstances in which required Studies in four soils must be carried out where in the absorption and desorption studies provided  for under point 7.1.2 it is not possible to obtain reliable absorption coefficient values. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 7.1.3.2. Aged residue column leaching Aim of the test The test should provide sufficient data to estimate the mobility and leaching potential of relevant  metabolites, degradation and reaction products. Circumstances in which required The studies must be performed except: -  where the nature and manner of use of preparations containing the active substance, preclude  soil contamination such as uses on stored products or wound healing treatments for trees, or -  where a separate study for the metabolite, degradation or reaction product in accordance to  point 7.1.2 or 7.1.3.1 was performed. Test conditions The period(s) of ageing should be determined from inspection of the degradation patterns of active  substance and metabolites to ensure that a relevant spectrum of metabolites is present at the time  of leaching. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 7.1.3.3. Lysimeter studies or field leaching studies Aim of the tests The test should provide data on: -  the mobility in soil, -  the potential for leaching to ground water, -  The potential distribution in soil. Circumstances in which requried Expert judgement will be necessary to decide whether lysimeter studies or field leaching studies  should be carried out, taking into account the results of degradation and other mobility studies  and the predicted environmental concentrations in groundwater (PECGW), calculated in accordance  with the provisions of Annex III, Section 9. The type and conditions of the study to be conducted  should be discussed with the competent authorities. Test conditions Great care is necessary in design of both experimental installations and individual studies, to  ensure that results obtained can be used for assessment purposes. Studies should cover the  realistic worst case situation, taking into account the soil type, climatic conditions, the  application rate and the frequency and period of application. Water percolating from soil columns must be analyzed at suitable intervals, while residues in plant  material must be determined at harvest. Residues in the soil profile in at least five layers must  be determined on termination of experimental work. Intermediate sampling must be avoided, since  removal of plants (except for harvesting according to normal agricultural practice) and soil cross  influences the leaching process. Precipitation, soil and air temperatures have to be recorded at regular intervals (at least on a  weekly base). -  Lysimeter studies Test conditions The minimal depth of the lysimeters should be 100 cm; their maximal depth should be 130 cm. The  soil cross must be undisturbed. Soil temperatures must be similar to those pertaining in the field.  Where necessary, supplementary irrigation must be provided to ensure optimal plant growth and to  ensure that the quantity of infiltration water is similar to that in the regions for which  authorization is sought. When during the study the soil has to be disturbed for agricultural  reasons it must not be disturbed deeper than 25 cm. -  Field leaching studies Test conditions Information on the groundwater table in the experimental fields must be submitted. If soil cracking  is observed during the study this must be fully described. Great attention should be given to the number and the location of water collection devices. The  placement of these devices in the soil should not result in preferential flow paths. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 7.2. Fate and behaviour in water and air Aim of the tests The information and data provided , taken together with that provided for one or more preparations  containing the active substance, and other relevant information, should be sufficient to establish,  or permit estimation of: -  persistence in water systems (bottom sediment and water, including suspended particles), -  the extent to which water, sediment organisms and air are at risk, -  potential for contamination of surface water and groundwater. 7.2.1. Route and rate of degradation in aquatic systemes (as far as not covered by point 2.9) Aim of the tests The data and information provided, together with other relevant data and information, should be  sufficient to: -  identify the relative importance of the types of processes involved (balance between chemical  and biological degradation), -  where possible, identify the individual components present, -  establish the relative proportions of the components present and their distribution as between  water, including suspended particles, and sediment, and -  permit the residue of concern and to which non-target species are or may be exposed, to be  defined. 7.2.1.1. Hydrolytic degradation Circumstances in which required The test must always be performed for relevant metabolites, degradation and reaction products which  account at any time for more than 10  % of the amount of active substance added unless sufficient  information on their degradation is available from the test performed in accordance with point  2.9.1. Test conditions and test guideline The same provisions as provided under the corresponding paragraphs of point 2.9.1 apply. 7.2.1.2. Photochemical degradation Circumstances in which required The test must always be performed for relevant metabolites, degradation and reaction products which  account at any time for more than 10  % of the amount of active substance added unless sufficient  information on their degradation is available from the test performed in accordance with points  2.9.2 and 2.9.3. Test conditions and test guideline The same provisions as provided under the corresponding paragraphs of points 2.9.2 and 2.9.3  apply. 7.2.1.3. Biological degradation 7.2.1.3.1. "Ready biodegradability" Circumstances in which required The test must always be performed unless it is not required under the provisions of Annex VI to  Directive 67/548/EEC for the classification of the active substance. Test guideline EEC method C4. 7.2.1.3.2. Water/sediment study Circumstances in which required The test must be reported unless it can be justified that contamination of surface water will not  occur. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 7.2.1.4. Degradation in the saturated zone Circumstances in which required Transformation rates in the saturated zone of active substances and of relevant metabolites,  degradation and reaction products can provide useful information on the fate of these substances in  the groundwater. Test conditions Expert judgement is required to decide whether this information is necessary. Before performing  these studies the applicant shall seek the agreement of the competent authorities on the type of  study to be performed. 7.2.2. Route and rate of degradation in air (as far as not covered by point 2.10) Guidance under development. 7.3. Definition of the residue In the light of the chemical composition of residues occurring in soil, water or air, resulting  from use, or proposed use, of a plant protection product containing the active substance a proposal  for the definition of the residue must be submitted, taking account of both the levels found and  their toxicological and environmental significance. 7.4. Monitoring data Available monitoring data concerning fate and behaviour of the active substance and relevant  metabolites, degradation and reaction products must be reported.` (1)     ANNEX II '9.  FATE AND BEHAVIOUR IN THE ENVIRONMENT Introduction (i)  The information provided, taken together with that for the active substance as provided for in  Annex II, must be sufficient to permit an assessment of the fate and behaviour of the plant  protection product in the environment, and of the non-target species likely to be at risk from  exposure to it. (ii)  In particular, the information provided for the plant protection product, together with other  relevant information, and that provided for the active substance, should be sufficient to: -  specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for  the protection of the environment, which are to be included on packaging (containers), -  predict the distribution, fate, and behaviour in the environment as well as the time courses  involved, -  identify non-target species and populations for which hazards arise because of potential  exposure, and -  identify measures necessary to minimize contamination of the environment and impact on  non-target species. (iii)  Where radio-labelled test material is used, the provisions of Annex II, Chapter 7,  introduction, point (iv) apply. (iv)  Where relevant tests should be designed and data analysed using appropriate statistical  methods. Full details of the statistical analysis should be reported (e.g. all point estimates should be  given with confidence intervals, exact p-values should be given rather than stating significant/non  significant). (v)  Predicted environmental concentrations in soil (PECS), water (PECSW and PECGW) and air  (PECA). Justified estimates must be made of the expected concentrations of the active substance and  relevant metabolites, degradation and reaction products, in soil, groundwater, surface water and  air, following use as proposed or already occurring. In addition a realistic worst-case estimation  must be made. For the purposes of the estimation of such concentrations the following definitions apply: -  Predicted environmental concentration in soil (PECS) The level of residues in the top layer of the soil and to which non-target soil organisms may be  exposed (acute and chronic exposure). -  Predicted environmental concentration in surface water (PECSW) The level of residues, in surface water to which non-target aquatic organisms may be exposed (acute  and chronic exposure). -  Predicted environmental concentration in groundwater (PECGW) The level of residues in groundwater. -  Predicted environmental concentration in air (PECA) The level of residues in air, to which man, animals and other non-target organisms may be exposed  (acute and chronic exposure). For the estimation of these concentrations all relevant information on the plant protection product  and on the active substance must be taken into account. A useful approach for these estimations is  provided in the EPPO schemes for environmental risk assessment  (1). Where relevant the parameters  provided for in this section should be used. When models are used for estimation of predicted environmental concentrations they must: -  make a best-possible estimation of all relevant processes involved taking into account realistic  parameters and assumptions, -  where possible be reliably validated with measurements carried out under circumstances relevant  for the use of the model, -  be relevant to the conditions in the area of use. The information provided must, where relevant, include that referred to in Annex II, Part A, point  7: and 9.1  Fate and behaviour in soil Where appropriate, the same provisions relating to the information to be provided on the soil used  and on its selection apply as provided for under Annex II, point 7.1. 9.1.1.  Rate of degradation in soil 9.1.1.1.  Laboratory studies Aim of the test The soil degradation studies should provide best possible estimates of the time taken for  degradation of 50 and 90  % (DT50lab and DT90lab) of the active substance under laboratory  conditions. Circumstances in which required The persistence and behaviour of plant protection products in soil must be investigated unless it  is possible to extrapolate from data obtained on the active substance and relevant metabolites,  degradation and reaction products in accordance to the requirements of Annex II, point 7.1.1.2.  This extrapolation is, for example, not possible for slow release formulations. Test conditions The rate of aerobic and/or anaerobic degradation in soil must be reported. The duration of the study is normally 120 days except if more than 90  % of the active substance is  degraded before that period expires. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 9.1.1.2.  Field studies -  Soil dissipation studies Aim of the test The soil dissipation studies should provide best-possible estimates of the time taken for  dissipation of 50 and 90  % (DT50f and DT90f), of the active substance under field conditions.  Where relevant, information on relevant metabolites, degradation and reaction products must be  collected. Circumstances in which required The dissipation and behaviour of plant protection products in soil must be investigated unless it  is possible to extrapolate from data obtained on the active substance and relevant metabolites,  degradation and reaction products in accordance to the requirements of Annex II, point 7.1.1.2.  This extrapolation is, for example, not possible for slow-release formulations. Test conditions and test guideline The same provisions as provided under the corresponding paragraph of Annex II, point 7.1.1.2.2.  apply. -  Soil residue studies Aim of the test Soil residue studies should provide estimates of the soil residue levels at harvest or at time of  sowing or planting succeeding crops. Circumstances in which required Soil residue studies must be reported unless it is possible to extrapolate from data obtained on  the active substance and relevant metabolites, degradation and reaction products in accordance with  the requirements of Annex II, point 7.1.1.2.2. This extrapolation is, for example, not possible for  slow-release formulations. Test conditions The same provisions as provided under the corresponding paragraph of Annex II, point 7.1.1.2.2.  apply. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. -  Soil accumulation studies Aim of the tests The tests should provide sufficient data to evaluate the possibility of accumulation of residues of  the active substance and of relevant metabolites, degradation and reaction products. Circumstances in which required Soil accumulation studies must be reported unless it is possible to extrapolate from data obtained  on the active substance and relevant metabolites, degradation and reaction products in accordance  with the requirements of Annex II, point 7.1.1.2.2. This extrapolation is, for example, not  possible for slow-release formulations. Test conditions The same provisions as provided under the corresponding paragraph of Annex II, point 7.1.1.2.2.  apply. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 9.1.2.  Mobility in the soil Aim of the test The test should provide sufficient data to evaluate the mobility and leaching potential of the  active substance and relevant metabolites, degradation and reaction products. 9.1.2.1. Laboratory studies Circumstances in which required The mobility of plant protection products in soil must be investigated unless it is possible to  extrapolate from data obtained in accordance with the requirements of Annex II, points 7.1.2 and  7.1.3.1. This extrapolation is, for example, not possible for slow-release formulations. Test guideline SETAC - Procedures for assessing the environmental fate and ecotoxicity of pesticides. 9.1.2.2. Lysimeter studies or field leaching studies Aim of the tests The test should provide data on: -  the mobility of the plant protection product in soil, -  the potential for leaching to ground water, -  the potential distribution in soils. Circumstances in which required Expert judgement will be necessary to decide whether field leaching studies or lysimeter studies  should be carried out, taking into account the results of degradation and mobility studies and the  calculated PECs. The type of study to be conducted should be discussed with the competent  authorities. These studies must be performed unless it is possible to extrapolate from data obtained on the  active substance and relevant metabolites, degradation and reaction products in accordance with the  requirements of Annex II, point 7.1.3. This extrapolation is, for example, not possible for slow  release formulations. Test conditions The same provisions as provided for under the corresponding paragraph of Annex II, point 7.1.3.3  apply. 9.1.3.  Estimation of expected concentrations in soil PECs estimations must relate both to a single application at the highest rate of application for  which authorization is sought, and to the maximum number and highest rates of application for which  authorization is sought, for each relevant soil tested, and are expressed in terms of mg of active  substance and of relevant metabolites, degradation and reaction products per kg of soil. The factors to be considered in making PECs estimations relate to direct and indirect application  to soil, drift, run off, and leaching and include processes such as volatilization, adsorption,  hydrolysis, photolysis, aerobic and anaerobic degradation. For the purposes of PECs calculations,  the bulk density of soils can be assumed to be 1,5 g/cm3 dry weight, while the depth of the soil  layer is assumed to be 5 cm for applications at the soil surface and 20 cm when incorporation in  the soil is involved. Where ground cover is present at time of application, it is to be assumed  that 50  % (minimum) of the applied dose reaches the soil surface unless actual experimental data  give more specific information. Initial, short-term and long-term PECs calculations (time weighted averages) must be provided: -  initial: immediately after application, -  short-term: 24 hours, 2 days and 4 days after last application, -  long-term: 7, 28, 50 and 100 days after last application, where relevant. 9.2.  Fate and behaviour in water 9.2.1.  Estimation of concentrations in groundwater The groundwater contamination routes have to be defined taking into account relevant agricultural,  plant health, and environmental (including climatic) conditions. Suitable estimations (calculations) of predicted environmental concentration in groundwater PECGW,  of active substance and relevant metabolites, degradation and reaction products, must be  submitted. PEC estimations must relate to the maximum number and highest rates of application, for which  authorization is sought. Expert judgment is required to decide if additional field tests could provide useful information.  Before performing these studies the applicant shall seek the agreement of the competent authorities  on the type of study to be performed. 9.2.2.  Impact on water treatment procedures In cases where this information is necessary in the framework of a conditional authorization as  meant in Annex VI, Part C, point 2.5.1.2 (b), the information provided should permit to establish  or to estimate effectiveness of water treatment procedures (drinking water and sewage treatment),  and impact on such procedures. Before performing any studies the applicant shall seek the agreement  of the competent authorities on the type of information to be provided. 9.2.3.  Estimation of concentrations in surface water The surface water contamination routes have to be defined taking into account relevant  agricultural, plant health, and environmental (including climatic) conditions. Suitable estimations (calculations) of predicted environmental concentration in surface water  PECsw, of active substance and relevant metabolites, degradation and reaction products, must be  submitted. PEC estimations must relate to the maximum number and highest rates of application, for which  authorization is sought, and be relevant to lakes, ponds, rivers, canals, streams,  irrigation/drainage canals and drains. The factors to be considered in making PECsw estimations relate to direct application to water,  drift, run-off, discharge via drains and atmospheric deposition, and include processes such as  volatilization, adsorption, advection, hydrolysis, photolysis, biodegradation, sedimentation and  re-suspension. Initial, short-term and long-term PECsw calculations relevant to static and slow moving water  bodies (time weighted averages) must be provided: -  initial: immediately after application, -  short-term: 24 hours, 2 days and 4 days after last application, -  long-term: 7, 14, 21, 28, and 42 days after last application, where relevant. Expert judgment is required to decide if additional field tests could provide useful information.  Before performing these studies the applicant shall seek the agreement of the competent authorities  on the type of study to be performed. 9.3.  Fate and behaviour in air Guidance under development.`


Avis juridique important

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31993L0015

Council Directive 93/15/EEC of 5 April 1993 on the harmonization of the provisions relating to the placing on the market and supervision of explosives for civil uses

Official Journal L 121 , 15/05/1993 P. 0020 - 0036 Finnish special edition: Chapter 15 Volume 12 P. 0185  Swedish special edition: Chapter 15 Volume 12 P. 0185

COUNCIL DIRECTIVE 93/15/EEC of 5 April 1993 on the harmonization of the provisions relating to the placing on the market and supervision of explosives for civil usesTHE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission(1) ,  In cooperation with the European Parliament(2) ,  Having regard to the opinion of the Economic and Social Committee(3) ,  Whereas Article 8a of the Treaty provides that the internal market must be established not later than 31 December 1992; whereas the internal market is to comprise an area without internal frontiers in which the free movement of goods, persons, services  and capital is ensured in accordance with the provisions of the Treaty;  Whereas Article 100a (3) of the Treaty provides that the Commission, in its proposals concerning safety, will take as a base a high level of protection;  Whereas the free movement of goods presupposes that certain basic conditions are fulfilled; whereas, in particular, the free movement of explosives presupposes harmonization of laws on the placing of explosives on the market;  Whereas explosives for civil uses are covered by detailed national regulations, mainly in respect of safety and security requirements; whereas such national regulations provide, in particular, that marketing authorizations be granted only where  explosives have satisfactorily undergone a series of tests;  Whereas harmonization of provisions governing the placing of such explosives on the market presupposes that divergent national rules will be harmonized in order to ensure the free movement of these products without lowering optimum levels of safety and  security;  Whereas this Directive defines only the essential requirements which must be met by explosives conformity tests; whereas, in order to facilitate the process of demonstrating compliance with the essential requirements, it would be very useful to process  standards harmonized at European level concerning, inter alia, methods for testing explosives; whereas such standards do not exist at present;  Whereas standards harmonized at European level are drawn up by private bodies and must retain their status as non-mandatory text; whereas, in this connection, the European Committee for Standardization (CEN) has been recognized as one of the two bodies  competent to adopt harmonized standards in accordance with the general guidelines for cooperation between the Commission and CEN and Cenelec, ratified on 13 November 1984; whereas, for the purposes of this Directive, 'harmonized standard' means a text  setting out technical specifications adopted by CEN under a mandate conferred by the Commission, in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical  standards and regulations(4)  and in keeping with the abovementioned general guidelines;  Whereas the Council, in its Decision 90/683/EEC of 13 December 1990 concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives(5) , introduced harmonized  means of applying procedures for conformity assessment; whereas the application of these modules to explosives will make it possible to determine the responsibility of manufacturers and of bodies responsible for applying procedures for conformity  assessment by taking account of the nature of the explosives concerned;  Whereas, as regards safety, the rules concerning the transport of explosives are covered by international conventions and agreements; whereas, at international level, there are United Nations recommendations on the transport of dangerous goods  (including explosives), the scope of which extends beyond the Community framework; whereas, in consequence, this Directive does not concern the transport rules;  Whereas, pyrotechnical articles require appropriate measures to ensure the protection of consumers and the safety of the public; whereas an additional directive is planned in this field;  Whereas the definition of the products covered by this Directive should be based on the definition of such products as set out in the abovementioned recommendations;  Whereas the scope of this Directive covers ammunition, but only as regards the rules governing controls on transfers and the associated arrangements; whereas, since ammunition is transferred under conditions similar to those under which arms are  transferred, transfers of ammunition should be governed by provisions similar to those applicable to arms, as set out in Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weapons(6) ;  Whereas the health and safety of workers producing or using explosives must also be protected; whereas an additional directive is in the course of preparation covering, inter alia, the health and safety of workers engaged in activities relating to the  manufacture, storage and use of explosives;  Whereas it is appropriate in the case of a serious threat to, or attack on, public safety by reason of the illicit possession or use of explosives or ammunition falling within this Directive, to allow Member States to derogate, under certain conditions,  from the provisions of this Directive with regard to transfer;  Whereas, finally, it is essential to establish administrative cooperation mechanisms; whereas it is appropriate in this connection for the competent authorities to base their approach on Council Regulation (EEC) No 1468/81 of 19 May 1981 on mutual  assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs or agricultural matters(7) ;  Whereas this Directive does not affect the power of Member States to take measures with a view to preventing illegal trade in explosives and ammunition,  HAS ADOPTED THIS DIRECTIVE:  CHAPTER I General provisions   Article 1  1.  This Directive shall apply to explosives as defined in paragraph 2.  2.  'Explosives' shall mean the materials and articles considered to be such in the United Nations recommendations on the transport of dangerous goods and falling within Class 1 of those recommendations.  3.  This Directive shall not apply to:  - explosives, including ammunition, intended for use, in accordance with national law, by the armed forces or the police,  - pyrotechnical articles,  - ammunition, except as provided in Articles 10, 11, 12, 13, 17, 18 and 19.  4.  For the purposes of this Directive:  - 'United Nations recommendations' shall mean the recommendations laid down by the United Nations Committee of Experts on the Transport of Dangerous Goods, as published in the UN (Orange Book) and as amended by the date when this Directive is adopted,  - 'safety' shall mean the prevention of accidents and, where prevention fails, the containment of their effects,  - 'security' shall mean the prevention of use contrary to law and order,  - 'dealer' shall mean any natural or legal person whose occupation consists wholly or partly in the manufacture, trade, exchange, hiring out, repair or conversion of fire arms and ammunition,  - 'approval' shall mean the decision taken to allow envisaged transfers of explosives within the Community,  - 'undertaking in the explosives sector' shall mean any natural or legal person possessing a licence or authorization which entitles him to engage in the manufacture, storage, use, transfer or trade in explosives,  - 'placing on the market' shall mean any first disposal against payment or free of charge of explosives covered by this Directive with a view to their distribution and/or use on the Community market,  - 'transfer' shall mean any physical movement of explosives within Community territory apart from movements within one and the same site.  5.  This Directive shall not prevent Member States from designating certain substances not covered by this Directive as explosives under national law or regulations.  CHAPTER II Harmonization of laws relating to explosives   Article 2  1.  Member States may not prohibit, restrict or hinder the placing on the market of explosives which fall within the scope of this Directive and which satisfy the requirements of this Directive.  2.  Member States shall take the necessary measures to ensure that explosives falling within the scope of this Directive may be placed on the market only if they comply with all the provisions of this Directive, are provided with the CE marking  described in Article 7 and their conformity has assessed in accordance with the procedures referred to in Annex II.  3.  Where explosives falling within the scope of this Directive are subject to other Directives which cover other aspects and prescribe the fixing of the CE marking, this marking shall indicate that the abovementioned products are also presumed to  conform to the provisions of these other directives which apply to them.  Article 3  Explosives falling within the scope of this Directive must comply with the essential safety requirements set out in Annex I which apply to them.  Article 4  1.  Member States shall consider explosives falling within the scope of this Directive which comply with the relevant national standards transposing the harmonized standards the references of which have been published in the Official Journal  of the European Communities to be in conformity with the essential safety requirements referred to in Article 3. Member States shall publish the references of the national standards transposing those harmonized standards.  2.  The Commission will give specific details of the work conducted in the field of harmonized standards in the framework of the report submitted to the European Parliament and the Council on the application of Directive 83/189/EEC and provided for in  Article 11 (2) of that Directive.  Article 5  Where a Member State or the Commission considers that the harmonized standards referred to in Article 4 do not fully satisfy the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the  matter before the Standing Committee set up by Directive 83/189/EEC, giving its reasons. The Committee shall deliver its opinion without delay.  In the light of the Committee's opinion the Commission shall inform the Member States of the measures to be taken regarding the standards and the publication referred to in Article 4.  Article 6  1.  The procedures for the attestation of the conformity of explosives shall be either:  (a) EC type examination (Module B) referred to in Annex II (1), and, at the choice of the manufacturer, either:  - the type conformity (Module C) referred to in Annex II (2),  - or the production quality assurance procedure (Module D) referred to in Annex II (3),  - or the product quality assurance procedure (Module E) referred to in Annex II (4),  - or the product verification (Module F) referred to in Annex II (5); or (b) the unit verification (Module G) referred to in Annex II (6).  2.  Member States shall inform the Commission and the other Member States of the bodies which they have appointed to carry out the procedures for assessing the conformity referred to above together with the specific tasks which these bodies have been  appointed to carry out and the identification numbers assigned to them beforehand by the Commission.  The Commission shall publish in the Official Journal of the European Communities a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to  date.  Member States shall apply the minimum criteria set out in Annex III for the assessment of bodies of which the Commission is to be notified. Bodies which meet the assessment criteria laid down by the relevant harmonized standards shall be presumed to  satisfy the relevant minimum criteria.  A Member State which hase notified the Commission of a given body shall withdraw the notification if it discovers that that body no longer meets the criteria referred to in the second subparagraph. It shall immediately inform the other Member States and  the Commission accordingly.  Article 7  1.  The CE marking of conformity shall be affixed in such a way as to be visible, easily legible and indelible on the explosives themselves or, if this is not possible, on an identification plate attached thereto or, in the last resort, if  the first two methods cannot be used, on the packaging. The identification plate must be so designed as to make its reuse impossible.  The model to be used for the CE marking shall be that reproduced in Annex IV.  2.  It shall be prohibited to affix on explosives any mark or inscription which may confuse third persons as to the meaning and style of writing of the CE marking. Any other mark may be affixed on explosives provided the visiblility and legibility of  the CE marking is not impaired.  3.  Without prejudice to the provisions of Article 8:  (a) where a Member State establishes that the CE marking has been unduly affixed, the manufacturer, his agent or, failing these, the person responsible for placing the product in question on the Community market shall be obliged to restore the product  to conformity with regard to the provisions on marking and end the infringement under conditions imposed by the Member States;  (b) where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market in accordance with the procedures laid  down in Article 8.  Article 8  1.  Where a Member State establishes that an explosive bearing CE conformity marking and being used for its intended purpose may compromise safety, it shall take all interim measures necessary to withdraw the explosive from the market or  prohibit its being placed on the market or its freedom of movement.  The Member State shall immediately inform the Commission of such measures, indicating the reasons for its measures and, in particular, whether non-conformity is the result of:  - non-compliance with essential requirements,  - incorrect application of standards, or - a shortcoming in the standards.  2.  The Commission shall consult the parties concerned as soon as possible. Where the Commission establishes, after consultation, that the measures are justified, it shall immediately inform the Member State which took the initiative, as well as the  other Member States. Where the Commission establishes, after consultation, that the measures are unjustified, it shall immediately inform the Member State which took the decision.  In the particular case where the measures referred to in paragraph 1 are based on a shortcoming in the standards, the Commission shall first consult the parties concerned and then within two months bring the matter before the Standing Committee set up  by Directive 83/189/EEC if the Member State which took the measures intends to maintain them and initiates the procedures referred to in Article 5.  3.  Where CE conformity marking is borne by an explosive which does not comply with the requirements, the competent Member State shall take appropriate measures in respect of the person who affixed the marking and shall inform the Commission and the  other Member States.  CHAPTER III Provisions governing the supervision of transfers in the Community   Article 9  1.  Explosives covered by this Directive may be transferred only in accordance with the following paragraphs.  2.  Controls performed pursuant to Community law or national law in the event of transfers of the explosives governed by this Article shall no longer be performed as internal frontier controls but solely as part of the normal control procedures applied  in a non-discriminatory fashion throughout the territory of the Community.  3.  Approval to transfer explosives shall be obtained by the consignee from the recipient competent authority. The competent authority shall verify that the consignee is legally authorized to acquire explosives and that he is in possession of the  necessary licences or authorizations. The person responsible for the transfer must notify the competent authorities of the transit Member State or Member States of movements of explosives through this or these States, whose approval shall be required.  4.  Where a Member State considers that there is a problem regarding the verification of the entitlement to acquire explosives referred to in paragraph 3, that Member State shall forward the available information on the subject to the Commission which  will put the matter before the Committee provided for in Article 12 without delay.  5.  Where the recipient competent authority approves a transfer, it shall issue to the consignee a document which includes all the information referred to in paragraph 7. Such a document must accompany the explosives until they arrive at their stated  destination. It must be produced at the request of the relevant competent authorities. A copy of this document shall be retained by the consignee who shall present it for examination by the recipient competent authority, at the latter's request.  6.  Where the competent authority of a Member State considers that special security requirements such as those referred to in paragraph 5 are unnecessary, explosives can be transferred on their territory or part thereof without prior provision of  information within the meaning of paragraph 7. The recipient competent authority shall then grant an approval for a fixed period and liable to suspension or withdrawal at any time on the basis of a reasoned justification. The document referred to in  paragraph 5, which must accompany the explosives until they arrive at their destination, shall refer solely to the abovementioned approval.  7.  Where transfers of explosives must be specially supervised in order to comply with special security requirements in the territory or part of the territory of a Member State, prior to the transfer the following information shall be provided by the  consignee to the recipient competent authority:  - the names and addresses of the operators concerned; this information must be detailed enough to enable the operators to be contacted and confirmation to be obtained that the persons in question are legally entitled to receive the consignment,  - the number and quantity of the explosives being transferred,  - a full description of the explosive in question and of the means of identification, including the United Nations identification number,  - where the explosives are to be placed on the market, information on compliance with conditions for placing on the market,  - the means of transfer and the itinerary,  - the expected dates of departure and arrrival,  - where necessary, the precise points of entry to and exit from Member States.  Recipient competent authorities shall examine the conditions under which the transfer may take place, with particular regard to the special security requirements. If the special security requirements are satisfied, approval for the transfer shall be  granted. In the event of transit through the territory of other Member States, those States shall likewise examine and approve, in the same conditions, the particulars concerning the transfer.  8.  Without prejudice to the normal checks which the Member State of departure shall carry out in its territory, at the request of the competent authorities concerned, the consignees and the operators concerned in the explosives sector shall forward to  the authorities of the Member State of departure and to those of the Member State of transit all relevant information they posses concerning the transfer of explosives.  9.  No supplier may transfer explosives unless the consignee has obtained the necessary authorizations for the transfer in accordance with the provisions of pargraphs 3, 5, 6 and 7.  Article 10  1.  Ammunition may be transferred from one Member State to another only in accordance with the procedure laid down in the following paragraphs. These provisions shall also apply to transfers of ammunition under mail-order sales.  2.  Where ammunition is to be transferred to another Member State the person concerned shall, before any dispatch, communicate to the Member State in which that ammunition is located:  - the names and addresses of the person selling or transferring the ammunition, of the person purchasing or acquiring the ammunition and, where appropriate, of the owner,  - the adress to which the ammunition is to be consigned or transported,  - the quantity of ammunition to be consigned or transported,  - data making it possible to identify the ammunition and also an indication that the ammunition has undergone a check in accordance with the Convention of 1 July 1969 on the Reciprocal Recognition of Proofmarks on Small Arms,  - the means of transfer,  - the date of departure and the estimated date of arrival.  The information referred to in the last two indents need not be supplied in the event of a transfer between dealers. The Member State shall examine the conditions under which the transfer is to be carried out, in particular with regard to security.  Where the Member State authorizes such a transfer it shall issue a licence incorporating all the particulars referred to in the first subparagraph. That licence shall accompany the ammunition until it reaches its destination; it shall be produced  whenever so required by the competent authorities of the Member States.  3.  Each Member State may grant dealers the right to effect transfers of ammunition from its territory to a dealer established in another Member State without the prior authorization referred to in paragraph 2. To that end it shall issue an  authorization valid for three years which may at any time be suspended or cancelled by reasoned decision. A document referring to that authorization must accompany the ammunition until it reaches its destination. It must be produced whenever so required  by the competent authorities of the Member States.  Before effecting the transfer, the dealer shall communicate to the authorities of the Member State from which the transfer is to be effected all the particulars listed in the first subparagraph of paragraph 2.  4.  Each Member State shall supply the other Member States with a list of the ammunition the transfer of which to its territory may be authorized without its prior consent.  Such lists of ammunition shall be communicated to dealers who have obtained approval for transferring ammunition without prior authorization under the procedure laid down in paragraph 3.  5.  Each Member State shall communicate all useful information at its disposal concerning definitive transfers of ammunition to the Member State, to the territory of which such a transfer has been effected.  All information that Member States receive by way of the procedures laid down in this Article shall be communicated, not later than the time of the relevant transfers, to the Member States of destination and, where appropriate, not later than the time  of transfer to the Member States of transit.  Article 11  By derogation from Article 9 (3), (5), (6) and (7), and from Article 10, a Member State, in case of grave threats to, or attacks upon, public security through the illicit possession or use of explosives or ammunition covered by the  Directive, may take all necessary measures concerning transfers of explosives or ammunition in order to prevent such illicit possession or use.  These measures shall respect the principle of proportionality. They must constitute neither a means of arbitrary discrimination nor a veiled restriction in trade between Member States.  Each Member State which adopts such measures shall notify the Commission of them forthwith; the Commission shall inform the other Member States thereof.  CHAPTER IV Other provisions   Article 12  1.  Member States shall set up information exchange networks for the implementation of Articles 9 and 10. They shall notify the other Member States and the Commission of the national authorities responsible for forwarding or receiving  information and for applying the procedures referred to in the said Articles 9 and 10.  2.  For the purpose of implementing this Directive, the provisions of Regulation (EEC) No 1468/81, in particular those relating to confidentiality, shall apply mutatis mutandis.  Article 13  1.  The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission.  The committee shall examine any matter concerning the application of this Directive raised by its chairman either on his own initiative or at the request of a representative of a Member State.  2.  The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter.  The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the  committee shall be weighted in the manner set out in that Article. The chairman shall not vote.  The Commission shall adopt measures which shall apply immediately. However, if these measures are not in accordance with the opinion of the committee, they shall be communicated by the Commission to the Council forthwith. In that event the Commission  shall defer application of the measures which it has decided for three months from the date of communication.  The Council, acting by a qualified majority, may take a different decision within the period referred to in the second subparagraph.  3.  The procedure laid down in paragraph 2 shall be followed in particular to take acount of any future amendments to the United Nations recommendations.  Article 14  Member States shall keep at the disposal of the other Member States and the Commission updated information concerning undertakings in the explosives sector possessing licences or authorizations as referred to in Article 1 (4).  Member States shall ascertain whether such undertakings possess a system for keeping track of explosives such that those holding explosives can be identified at any time. The conditions for the application of this subparagraph shall be adopted in  accordance with the committee procedure provided for in Article 13.  Undertakings in the explosives sector shall keep such records of their transactions as are necessary to fulfil the obligations set out in this Article.  The documents referred to in this Article must be kept for at least three years after the end of the calendar year in which the recorded transaction took place, even if the undertaking has ceased trading. They must be immediately available for  inspection at the request of the competent authorities.  Article 15  Member States shall ensure that explosives are properly marked.  Article 16  When a Member State issues a licence or authorzation for the purpose of allowing an explosives manufacturing activity to be exercised, it shall check in particular that the persons responsible are capable of complying with the technical  commitments they assume.  CHAPTER V Final provisions   Article 17  Each Member State shall determine the penalties to be applied for infringement of the provisions adopted in implementation of this Directive. The penalties shall be sufficient to promote compliance with those provisions.  Article 18  Each Member State shall adopt, in the context of its national law, the necessary measures to enable the competent authorities to seize any product coming within the scope of this Directive if there is sufficient evidence that that product  will be illictly acquired, used or dealt in.  Article 19  1.  Member States shall bring into force the provisions necessary to comply with Articles 9, 10, 11, 12, 13 and 14 before 30 September 1993.  2.  Member States shall adopt and publish before 30 June 1994 the laws, regulations and administrative provisions necessary to comply with the provisions other than those mentioned in paragraph 1. They shall forthwith inform the Commission thereof.  They shall apply these provisions as from 1 January 1995.  3.  When Member States adopt the provisions referred to in paragraphs 1 and 2 those provisions shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making  such a reference shall be determined by the Member States.  4.  However, during the period up to 31 December 2002, Member States shall allow the placing on the markets of explosives complying with the national regulations in force in their territory before 31 December 1994.  5.  Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive.  Article 20  This Directive is addressed to the Member States.  Done at Luxembourg, 5 April 1993.  For the Council The President J. TROEJBORG   (1) OJ No C 121, 13. 5. 1992, p. 19.  (2) OJ No C 305, 23. 11. 1992, p. 128; and OJ No C 115, 26. 4. 1993.  (3) OJ No C 313, 30. 11. 1992, p. 13.  (4) OJ No L 109, 26. 4. 1983, p. 8. Directive as last amended by Commission Decision 90/230/EEC (OJ No L 128, 18. 5. 1990, p. 15).  (5) OJ No L 380, 31. 12. 1990, p. 13.  (6) OJ No L 256, 13. 9. 1991.  (7) OJ No L 144, 2. 6. 1981, p. 1. Regulation as amended by Regulation (EEC) No 945/87 (OJ No L 90, 2. 4. 1987, p. 4.)   ANNEX I  ESSENTIAL SAFTETY-REQUIREMENTS  I. General requirements 1. Each explosive must be designed, manufactured and supplied in such a way as to present a minimal risk to the safety of human life and health, and to prevent damage to property and the environment under normal, foreseeable conditions, in particular as  regards the safety rules and standard practices including until such time as it is used.  2. Each explosive must attain the performance characteristics specified by the manufacturer in order to ensure maximum safety and reliability.  3. Each explosive must be designed and manufactured in such a way that when appropriate techniques are employed it can be disposed of in a manner which minimizes effects on the environment.  II. Special requirements 1. As a minimum, the following information and properties - where appropriate - must be considered. Each explosive should be tested under realistic conditions. If this is not possible in a laboratory, the tests should be carried out in the conditions in  which the explosive is to be used.  (a) Construction and characteristic properties, including chemical composition, degree of blending and, where appropriate, dimensions and grain size distribution.  (b) The physical and chemical stability of the explosive in all environmental conditions to which it may be exposed.  (c) Sensitiveness to impact and friction.  (d) Compatibility of all components as regards their physical and chemical stability.  (e) The chemical purity of the explosive.  (f) Resistance of the explosive against influence of water where it is intended to be used in humid or wet conditions and where its safety or reliability may be adversely affected by water.  (g) Resistance to low and high temperatures, where the explosive is intended to be kept or used at such temperatures and its safety or reliability may be adversely affected by cooling or heating of a component or of the explosive as a whole.  (h) The suitability of the explosive for use in hazardous environments (e.g. environment endangered by firedamp, hot masses, etc.) if it is intended to be used under such conditions.  (i) Safety features intended to prevent untimely or inadvertent initiation or ignition.  (j) The correct loading and functioning of the explosive when used for its intended purpose.  (k) Suitable instructions and, where necessary, markings in respect of safe handling, storage, use and disposal in the official language or languages of the recipient Member State.  (l) The ability of the explosive, its covering or other components to withstand deterioration during storage until the 'use by' date specified by the manufacturer.  (m) Specification of all devices and accessories needed for reliable and safe functioning of the explosive.  2. The various groups of explosives must at least also comply with the following requirements:  A. Blasting explosives (a) The proposed method of initiation must ensure safe, reliable and complete detonation or deflagration as appropriate, of the blasting explosive. In the particular case of black powder, it is the capacity as regards deflagration which shall be  checked.  (b) Blasting explosives in cartridge form must transmit the detonation safely and reliably from one end of the train of cartridges to the other.  (c) The gases produced by blasting explosives intended for underground use may contain carbon monoxide, nitrous gases, other gases, vapours or airborn solid residues only in quantities which do not impair health under normal operating conditions.  B. Detonating cords, safety fuses, igniter cords and shock tubes (a) The covering of detonating cords, safety fuses and igniter cords must be of adequate mechanical strength and adequately protect the explosive filling when exposed to normal mechanical stress.  (b) The parameters for the burning times of safety fuses must be indicated and must be reliably met.  (c) Detonating cords must be capable of being reliably initiated, be of sufficient initiation capability and comply with requirements as regards storage even in particular climatic conditions.  C. Detonators (including delay detonators) and relays (a) Detonators must reliably initiate the detonation of the blasting explosives which are intended to be used with them under all foreseeable conditions of use.  (b) Relays must be capable of being reliably initiated.  (c) The initiation capability must not be adversely affected by humidity.  (d) The delay times of delay detonators must be sufficiently uniform to ensure that the probability of overlapping of the delay times of adjacent time steps is insignificant.  (e) The electrical characteristics of electric detonators must be indicated on the packaging (e.g. no-fire current, resistance, etc.).  (f) The wires of electric detonators must be of sufficient insulation and mechanical strength including the solidity of the link to the detonator, taking account of their intended use.  D. Propellants and rocket propellants (a) These materials must not detonate when used for their intended purpose.  (b) Propellants where necessary (e.g. those based on nitrocellulose) must be stabilized against decomposition.  (c) Solid rocket propellants, when in compressed or cast form, must not contain any unintentional fissures or gas bubbles which dangerously affect their functioning.    ANNEX II 1. MODULE B: EC type-examination 1. This module describes that part of the procedure by which a notified body ascertains and attests that an example, representative of the production envisaged, meets the relevant provisions of the Directive.  2. The application for EC type-examination is lodged by the manufacturer or his authorized representative established within the Community with a notified body of his choice.  The application must include:  - the name and address of the manufacturer and, if the application is lodged by the authorized representative, the name and address in addition,  - a written declaration that the same application has not been lodged with any other notified body,  - the technical documents, as described in Section 3.  The applicant must place at the disposal of the notified body an example representative of the production envisaged, hereinafter called 'type'. The notified body may request further examples if needed for carrying out the test programme.  3. The technical documents must enable the conformity of the appliance with the requirements of the Directive to be assessed. They must, as far as is relevant for such assessment, cover the design, manufacture and operation of the appliance and contain  as far as is relevant for assessment:  - a general type-description,  - conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,  - descriptions and explanations necessary for the understanding of the drawings and diagrams and the operation of the product,  - a list of the standards referred to in Article 4, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,  - results of design calculations made, examinations carried out, etc.,  - test reports.  4. The notified body must:  4.1. examine the technical documents, verify that the type has been manufactured in conformity with those documents and identify the elements which have been designed in accordance with the relevant provisions of the standards referred to in Article 4  as well as the components which have been designed without applying the relevant provisions of those standards;  4.2. perform or have performed the appropriate examinations and necessary tests to check whether, where the standards referred to in Article 4 have not been applied, the solutions adopted by the manufacturer meet the essential requirements of the  Directive;  4.3. perform or have performed the appropriate examinations and necessary tests to check whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied;  4.4. agree with the applicant the location where the examinations and necessary tests are to be carried out.  5. Where the type meets the relevant provisions of this Directive, the notified body issues an EC type-examination certificate to the applicant. The certificate contains the name and addres of the manufacturer, the conclusion of the examination and  necessary data for identification of the approved type. A list of the relevant parts of the technical documents is annexed to the certificate and a copy kept by the notified body.  If the manufacturer or his authorized representative established in the Community is refused a type certificate, the notified body must provide detailed reasons for such refusal.  Provision must be made for an appeals procedure.  6. The applicant informs the notified body that holds the technical documents concerning the EC type-examination certificate of all modidfications to the approved appliance which must receive additional approval where such changes may affect the  conformity with the essential requirements or the prescribed conditions for use of the product. This additional approval is given in the form of an addition to the original EC type-examination certificate.  7. Each notified body must communicate to the other notified bodies the relevant information concerning the EC type-examination certificates and additions issued and withdrawn.  8. The other notified bodies may receive copies of the EC type-examination certificates and/or their additions. The Annexes to the certificates must be kept at the disposal of the other notified bodies.  9. The manufacturer or his authorized representative established within the Community must keep with the technical documents copies of EC type-examination certificates and their additions for a period of at least 10 years after the last date of  manufacture of the product concerned.  Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documents available is the responsibility of the person who places the product on the Community market.  2. MODULE C: Conformity to type 1. This module describes that part of the procedure whereby the manufacturer or his authorized representative established within the Community ensures and declares that the explosives concerned are in conformity with the type as described in the EC  type-examination certificate and satisfy the requirements of this Directive that apply to them. The manufacturer must affix the CE mark to each explosive and draw up a written declaration of conformity.  2. The manufacturer must take all measures necessary to ensure that the manufacturing process assures the conformity of the manufactured product with the type as described in the EC type-examination certificate with the essential safety requirements of  the Directive.  3. The manufacturer or his authorized representative must keep a copy of the declaration of conformity for a period of at least 10 years after the last date of manufacture of the product concerned.  Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documents available is the responsibility of the person who places the product on the Community market.  4. A notified body chosen by the manufacturer must perform or have performed examinations of the product at random intervals. A suitable sample of the finished products, taken on the spot by the notified body, is examined and appropriate test, defined  in the applicable standard or standards referred to in Article 4 or equivalent tests are carried out to check the conformity of the product with the requirements of the corresponding Directive. In the event of one or more samples of the products  examined not conforming, the notified body must take the appropriate measures.  Under the responsibility of the notified body the manufacturer shall affix the identification symbol of that body during the manufacturing process.  3. MODULE D: Production quality assurance 1. This module describes the procedure whereby the manufacturer who satisfies the obligations of Section 2 ensures and declares that the explosives concerned are in conformity with the type as described in the EC type-examination certificate and satisfy  the requirements of this Directive. The manufacturer affixes the CE mark to each explosive and draws up a written declaration of conformity. The CE mark is accompanied by the identification symbol of the notified body responsible for the checks referred  to in Section 4.  2. The manufacturer must operate an approved quality system for production, final product inspection and testing as specified in Section 3. He is subject to the checks referred to in Section 4.  3. Quality system 3.1. The manufacturer lodges an application for assessment of his quality system with a notified body of his choice, for the explosives concerned.  The application must include:  - all relevant information for the explosive category envisaged,  - the documents concerning the quality system,  - the technical documents pertaining to the approved type and a copy of the EC type-examination certificate.  3.2. The quality system must ensure conformity of explosives with the type as described in the EC type-examination certificate and with the requirements of this Directive that apply to them.  All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documents must permit a consistent  interpretation of the quality programmes, plans, manuals and quality records.  It must contain in particular an adequate description of:  - the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the explosives,  - the manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,  - the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,  - the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.,  - the means of monitoring the achievement of the required quality of explosive and the effective operation of the quality system.  3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 3.2. It must presume conformity with those requirements in respect of quality systems that implement the relevant harmonized  standard. The auditing team must have at least one member with experience of assessing the relevant product technology. The assessment procedure includes an inspection visit to the manufacturer's premises.  The decision is notified to the manufacturer. The notification must contain the conlusions of the examination and the duly substantiated assessment decision.  3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and maintain it at an adequate and efficient level.  The manufacturer or his authorized representative must keep the notified body that has approved the quality system informed of any proposed change in the quality system.  The notified body must assess the changes proposed an decide whether the altered quality system will still satisfy the requirements referred to in 3.2 or whether reassessment is required.  It must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the substantiated assessment decision.  4. Monitoring under the responsibility of the notified body 4.1 The purpose of monitoring is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.  4.2 The manufacturer must allow the notified body access for inspection purposes to the manufacturing, inspection, testing and storage premises and provide it with all necessary information, in particular:  - the quality system documents,  - the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.  4.3. The notified body must periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and provides an audit report to the manufacturer.  4.4. Additionally the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out tests or have them carried out to verify that the quality system is functioning correctly; if necessary, the notified  body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.  5. The manufacturer must, for a period of at least 10 years after the last date of manufacture of the product, keep at the disposal of the national authorities:  - the document referred to in the second indent of 3.1,  - the updating referred to in second paragraph of 3.4,  - the decisions and reports form the notified body which are referred to in the final paragraph of 3.4, and in 4.3 and 4.4.  6. Each notified body must give the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.  4. MODULE E: Product quality assurance 1. This module describes the procedure whereby the manufacturer who satisfies the obligations of Section 2 ensures and declares that the explosives are in conformity with the type as described in the EC type-examination certificate. The manufacturer  must affix the CE mark to each explosive and draw up a written declaration of conformity. The CE mark must be accompanied by the identification symbol of the notified body responsible for the checks referred to in Section 4.  2. The manufacturer must operate an approved quality system for final explosive inspection and testing as specified in Section 3. He must be subject to the checks referred to in Section 4.  3. Quality system 3.1.  The manufacturer lodges an application with a notified body of his choice for the assessment of the quality system for his explosives.  The application must include:  - all relevant information for the explosive category envisaged,  - the quality system's documentation,  - the technical documents pertaining to the approved type and a copy of the EC type-examination certificate.  3.2. Under the quality system, each explosive is examined and appropriate tests as defined in the relevant standard(s) referred to in Article 4 or equivalent tests are carried out in order to verify its conformity with the relevant requirements of the  Directive. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must enable the  quality programmes, plans, manuals and records to be interpreted in a uniform manner.  It must in particular contain an adequate description of:  - the quality objectives and the organizational structure, responsilities and powers of the management with regard to product quality,  - the examination and tests that will be carried out after manufacture,  - the means of monitoring the effective operation of the quality system,  - quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.  3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 3.2. It must presume conformity with these requirements in respect of quality systems that implement the relevant harmonized  standard.  The auditing team must have at least one member with experience of assessing the relevant product technology. The assessment procedure must include an inspection visit to the manufacturer's premises.  The manufacturer must be notified of the decision. The notification must contain the conclusions of the examination and the substantiated assessment decision.  3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and maintain it at an adequate and efficient level.  The manufacturer or his authorized representative must keep the notified body which has approved the quality system informed of any proposed change in the quality system.  The notified body must assess the changes proposed and decide whether the altered quality system will still satisfy the requirements referred to in 3.2 or whether a reassessment is required.  It must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the substantiated assessment decision.  4.1. The purpose of monitoring is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.  4.2. The manufacturer must allow the notified body access for inspection purposes to the inspection, testing and storage premises and provide it with all necessary information, in particular:  - the quality system documentation,  - the technical documents,  - the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.  4.3. The notified body must periodically carry out audits to ensure that the manufacturer maintains and applies the quality system and must provide an audit report to the manufacturer.  4.4. Additionally, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out tests or have them carried out to verify that the quality system is functioning correctly; if necessary, the notified  body must provide the manufacturer with a visit report and, if a test has been carried out, with a test reports.  5. The manufacturer must for a period of at least 10 years after the last date of manufacture of the product keep at the disposal of the national authorities:  - the documents referred to in the second indent of 3.1,  - the changes referred to in the second paragraph of 3.4,  - the decisions and reports form the notified body which are referred to in the final paragraph of 3.4, and in 4.3 and 4.4.  6. Each notified body must forward to the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.  5. MODULE F: Product verification 1. This module describes the procedure whereby a manufacturer or his authorized representative established within the Community checks and attests that the explosives subject to the provisions of 3 are in conformity with the type as described in the EC  type-examination certificate and satisfy the relevant requirements of the Directive.  2. The manufacturer shall take all measures necessary in order that the manufacturing process ensures conformity of the explosives with the type as described in the EC type-examination certificate and with the requirements of the Directive that apply to  them. He shall affix the CE mark to each explosive and shall draw up a declaration of conformity.  3. The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the explosive with the relevant requirements of the Directive by examination and testing of every explosive as specified in 4.  The manufacturer or his authorized representative shall keep a copy of the declaration of conformity for a period ending at least 10 years after the last explosive has been manufactured.  4. Verification by examination and testing of every explosive 4.1. All explosives shall be individually examined and appropriate tests as set out in the relevant standard(s) referred to in Article 4 or equivalent tests shall be carried out in order to verify their conformity with the relevant type and requirements  of the Directive.  4.2. The notified body shall affix or cause to be affixed, its identification symbol to each approved explosive and draw up a written certificate of conformity relating to the tests carried out.  4.3. The manufacturer or his authorized representative shall ensure that he is able to supply the notified body's certificates of conformity on request.  6. MODULE G: Unit verification 1. This module describes the procedure whereby the manufacturer ensures and declares that the explosive which has been issued with the certificate referred to in Section 2 conforms to the relevant requirements of the Directive. The manufacturer must  affix the CE mark to the explosive and draw up a declaration of conformity.  2. The notified body must examine the explosive and carry out the appropriate tests as set out in the relevant standard(s) referred to in Article 4, or equivalent tests, to ensure its conformity with the relevant requirements of the Directive.  The notified body must affix, or cuase to be affixed, its identification symbol on the approved explosive and draw up a certificate of conformity concerning the tests carried out.  3. The aim of the technical documents is to enable conformity with the requirements of the Directive to be assessed and the design, manufacture and operation of the explosive to be understood.  The documents must contain, in so far as is necessary for the assessment:  - a general description of the type,  - conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,  - descriptions and explanations necessary for the understanding of the said drawings and schemes and the operation of the explosive or protection system,  - a list of the standards referred to in Article 4, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 4 have not been applied,  - results of design calculations made, examinations carried out, etc.,  - test reports.    ANNEX III  MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES FOR THE NOTIFICATION OF BODIES  1. The body, its director and the staff responsible for carrying out the verification tests shall not be the designer, manufacturer, supplier or installer of  explosives which they inspect, nor the authorized representative of any of these parties. They shall not become either involved directly or as authorized representatives in the design, construction, markteting or maintenance of such explosives. This  does not preclude the possibility of exchanges of technical information between the manufacturer and the body.  2. The body and its staff shall carry out the verification tests with the highest degree of professional integrity and technical competence and shall be free from all pressures and inducements, paritcularly financial, which might influence thier  judgement or the results of the inspection, especially from persons or groups of persons with an interest in the result of verifications.  3. The body shall have at is disposal the necessary staff and possess the necessary facilities to enable it to perform properly the administrative and technical tasks connected with verification; it shall also have access to the equipment required for  special verification.  4. The staff responsible for inspection shall have:  - sound technical and professional training,  - satisfactory knowledge of the requirments of the tests they carry out and andequate experience of such tests,  - the ability to draw up the certificates, records and reports required to authenticate the performance of the tests.  5. The impartiality of inspection staff shall be guaranteed. Their remuneration shall not depend on the number of tests carried out or on the results of such tests.  6. The body shall take out civil liability insurance unless its liability is assumend by the State in accordance with national law, or the Member State itself is directly responsible for the tests.  7. The staff of the body shall be bound to observe professional secrecy with regard to all information gained in carrying out its tasks (except vis-á-vis) the competent administrative authorities of the State in which its activities are carried out)  under this Directive or any provision of national law giving effect to it.    ANNEX IV  CONFORMITY MARKING  The CE conformity marking shall consist of the initials 'CE' taking the following form:  If the marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.