### an organic soil improver shall consist exclusively of material of solely biological origin , excluding material which is fossilized or embedded in geological formations . ### an organic soil improver shall consist exclusively of material of solely biological origin , including peat , leonardite , lignite and humic substances obtained from them , but excluding other materials which are fossilized or embedded in geological formations .


### organic carbon shall be present in the ce marked fertilising product by at least 3 % by mass . ### organic carbon shall be present in the ce marked fertilising product by at least 1 % by mass .


### proposal for a regulation of the european parliament and of the council laying down rules on the making available on the market of ce marked fertilising products and amending regulations no 1069 / 2009 and no 1107 / 2009 ### proposal for a regulation of the european parliament and of the council laying down rules on the making available on the market of ce marked fertilisers and improving nutrition efficiency products and amending regulations no 1069 / 2009 , no 1107 / 2009 and no 1907 / 2006


### certain substances and mixtures , commonly referred to as agronomic additives , improve the nutrient release pattern of a nutrient in a fertiliser . substances and mixtures made available on the market with the intention of them being added to ce marked fertilising products for that purpose should fulfil certain efficacy criteria at the responsibility of the manufacturer of those substances or mixtures , and should therefore as such be considered as ce marked fertilising products under this regulation . furthermore , ce marked fertilising products containing such substances or mixtures should be subject to certain efficacy and safety criteria . such substances and mixtures should therefore also be regulated as component materials for ce marked fertilising products . ### certain substances and mixtures , referred to as agronomic additives , improve the nutrient release pattern of a nutrient in a fertiliser . substances and mixtures made available on the market with the intention of them being added to ce marked fertilising products for that purpose should fulfil certain efficacy criteria at the responsibility of the manufacturer of those substances or mixtures , and should therefore as such be considered as ce marked fertilising products under this regulation . furthermore , ce marked fertilising products containing such substances or mixtures should be subject to certain efficacy and safety criteria . such substances and mixtures should therefore also be regulated as component materials for ce marked fertilising products .


### –where soft ground phosphate is present , phosphorus pentoxide soluble in formic acid ; ### –phosphorus pentoxide only soluble in mineral acids ;


### manufacturers shall ensure that ce marked fertilising products are labelled in accordance with annex iii , or where the fertilising product is supplied without packaging , that the labelling statements are provided in a document accompanying the fertilising product and accessible for inspection purposes when the product is placed on the market . the labelling statement shall be in a language which can be easily understood by end - users , as determined by the member state concerned , and shall be clear , understandable and intelligible . ### manufacturers shall ensure that ce marked fertilising products are labelled in accordance with annex iii . where the fertilising product is supplied in a package the information shall appear on a label , which is affixed to the package . however , where the package is too small to contain all the information , some information shall be provided in a separate leaflet accompanying the package . such a leaflet shall be regarded as part of the label . where the fertilising product is supplied without packaging , all information shall be provided in such a leaflet . the information shall be in a language which can be easily understood by end - users , as determined by the member state concerned , and shall be clear , understandable and intelligible .


### - 1 , 5% by mass of total potassium oxide , ### - 3% by mass of total potassium oxide , or


### when placing a ce marked fertilising product on the market , the importer should indicate on the packaging of the fertilising product his or her name , registered trade name or registered trade mark and the postal address at which he or she can be contacted , in order to enable market surveillance . ### when placing a ce marked product on the market , the importer should indicate on the packaging of the product his or her name , registered trade name or registered trade mark and the postal address at which he or she can be contacted , as well as the foreign manufacturer and the country of origin of the product in order to enable market surveillance .


### the commission shall be empowered to adopt delegated acts in accordance with article 43 to amend annexes i to iv for the purposes of adapting them to technical progress and facilitating internal market access and free movement for ce marked fertilising products ### the commission shall be empowered to adopt delegated acts in accordance with article 43 to amend annexes iii to iv for the purposes of adapting them to technical progress and facilitating internal market access and free movement for ce marked fertilising products


### ce - marked fertilising products should be placed on the market only if they are sufficiently effective and do not present unacceptable risks to human , animal or plant health , to safety or to the environment when properly stored and used for their intended purpose , and under conditions of use which can be reasonably foreseen , that is when such use could result from lawful and readily predictable human behaviour . therefore , requirements for safety and quality , as well as appropriate control mechanisms , should be established . furthermore , the intended use of ce marked fertilising products should not lead to food or feed becoming unsafe . ### ce - marked fertilising products should be placed on the market only if they are sufficiently effective and do not present risks to human , animal or plant health , to safety or to the environment when properly stored and used for their intended purpose , and under conditions of use which can be reasonably foreseen , that is when such use could result from lawful and readily predictable human behaviour . therefore , requirements for safety and quality , as well as appropriate control mechanisms , should be established .


### - 1 , 5% by mass of total nitrogen , ### - 3% by mass of total nitrogen , or


### ce - marked fertilising products should be placed on the market only if they are sufficiently effective and do not present unacceptable risks to human , animal or plant health , to safety or to the environment when properly stored and used for their intended purpose , and under conditions of use which can be reasonably foreseen , that is when such use could result from lawful and readily predictable human behaviour . therefore , requirements for safety and quality , as well as appropriate control mechanisms , should be established . furthermore , the intended use of ce marked fertilising products should not lead to food or feed becoming unsafe . ### ce - marked products should be placed on the market only if they have proved their agronomic efficacy and do not present unacceptable risks to human , animal or plant health , to safety or to the environment when properly stored and used for their intended purpose , and under conditions of use which can be reasonably foreseen , that is when such use could result from lawful and readily predictable human behaviour . therefore , requirements for safety and quality , as well as appropriate control mechanisms , should be established . furthermore , the intended use of ce marked fertilising products should not lead to food or feed becoming unsafe .


### organic carbon : ± 20 % relative deviation of the declared value up to a maximum of 2 , 0 percentage point in absolute terms organic nitrogen : ± 50 % relative deviation of the declared value up to a maximum of 1 , 0 percentage point in absolute terms total copper ± 50 % relative deviation of the declared value up to a maximum of 2 , 5 percentage points in absolute terms total zinc ± 50 % relative deviation of the declared value up to a maximum of 2 , 0 percentage points in absolute terms ### organic carbon : ± 15 % relative deviation of the declared value up to a maximum of 2 , 0 percentage point in absolute terms organic nitrogen : ± 15 % relative deviation of the declared value up to a maximum of 1 , 0 percentage point in absolute terms total copper ± 15 % relative deviation of the declared value up to a maximum of 2 , 5 percentage points in absolute terms total zinc ± 15 % relative deviation of the declared value up to a maximum of 2 , 0 percentage points in absolute terms


### a compound solid inorganic macronutrient fertiliser shall have a declared content of more than one nutrient . ### a compound solid mineral macronutrient fertiliser shall have a declared content of more than one primary nutrient .


### manufacturers shall ensure that procedures are in place for ce marked fertilising products that are part of a series production to remain in conformity with this regulation . changes in production method or characteristics of those fertilising products and changes in the harmonised standards , common specifications referred to in article 13 or other technical specifications by reference to which conformity of a ce marked fertilising product is declared shall be adequately taken into account . ### manufacturers shall ensure that procedures are in place for ce marked fertilising products that are part of a series production to remain in conformity with this regulation . changes in characteristics of those fertilising products and changes in the harmonised standards , common specifications referred to in article 13 or other technical specifications by reference to which conformity of a ce marked fertilising product is declared shall be adequately taken into account .


### - lead 120 mg / kg dry matter . ### - lead 20 mg / kg dry matter .


### - lead 120 mg / kg dry matter , and ### - lead 20 mg / kg dry matter , and


### –1 , 5% by mass of total sulphur trioxide , or ### –5% by mass of total sulphur trioxide ,


### a blend of different ce marked fertilising products , each of which has been subject to a successful assessment of conformity with the applicable requirements for that material , can itself be expected to be suitable for use as a ce marked fertilising product , subject only to certain additional requirements warranted by the blending . therefore , in order to avoid an unnecessary administrative burden , such blends should belong to a separate category , for which the conformity assessment should be limited to the additional requirements warranted by the blending . ### a combination of different ce marked fertilising products , each of which has been subject to a successful assessment of conformity with the applicable requirements for that material , can itself be expected to be suitable for use as a ce marked fertilising product , subject only to certain additional requirements warranted by the mixing . therefore , in order to avoid an unnecessary administrative burden , such combinations should belong to a separate category , for which the conformity assessment should be limited to the additional requirements warranted by the mixing .


### the ce marking shall be affixed visibly , legibly and indelibly to the accompanying documents and , where the ce marked fertilising product is supplied in a packaged form , to the packaging . ### the ce marking shall be affixed visibly , legibly and indelibly to the packaging of the ce marked fertilising product or , where the ce marked fertilising product is supplied without packaging , to the documents accompanying the ce marked fertilising product .


### forms of the declared nutrient and other declared quality criteria ph organic carbon total nitrogen total phosphorus pentoxide total potassium oxide dry matter quantity carbon org / nitrogen org granulometry forms of the declared nutrient and other declared quality criteria ph organic carbon total nitrogen total phosphorus pentoxide total potassium oxide dry matter quantity carbon org / nitrogen org granulometry ### permissible tolerances for the declared parameter ± 0 , 7 at the time of manufacture ± 1 , 0 at any time in the distribution chain ± 10% relative deviation of the declared value up to a maximum of 1 , 0 percentage points in absolute terms ± 20% relative deviation up to a maximum of 1 , 0 percentage point in absolute terms ± 20% relative deviation up to a maximum of 1 , 0 percentage point in absolute terms ± 20% relative deviation up to a maximum of 1 , 0 percentage point in absolute terms ± 10% relative deviation of the declared value - 5% relative deviation of the declared value at the time of manufacture - 25% relative deviation of the declared value at any time in the distribution chain ± 20% relative deviation of the declared value up to a maximum of 2 , 0 percentage points in absolute terms ± 10 % relative deviation applicable to the declared percentage of material passing a specific sieve . permissible tolerances for the declared parameter ± 0 , 7 at the time of manufacture ± 1 , 0 at any time in the manufacturing chain ± 10% relative deviation of the declared value up to a maximum of 1 , 0 percentage points in absolute terms ± 20% relative deviation up to a maximum of 1 , 0 percentage point in absolute terms ± 20% relative deviation up to a maximum of 1 , 0 percentage point in absolute terms ± 20% relative deviation up to a maximum of 1 , 0 percentage point in absolute terms ± 10% relative deviation of the declared value - 5% relative deviation of the declared value at the time of manufacture - 25% relative deviation of the declared value at any time in the manufacturing chain ± 20% relative deviation of the declared value up to a maximum of 2 , 0 percentage points in absolute terms ± 10 % relative deviation applicable to the declared percentage of material passing a specific sieve .


### –0 , 5% by mass of total sodium oxide . ### –from 0 , 5% to 5% by mass of total sodium oxide .


### forms of the declared nutrient and other declared quality criteria electric conductivity ph quantity by volume quantity determination of materials with particle size greater than 60 mm quantity determination of pre - shaped gm water - soluble nitrogen water - soluble phosphorus pentoxide water - soluble potassium oxide forms of the declared nutrient and other declared quality criteria electric conductivity ph quantity by volume quantity determination of materials with particle size greater than 60 mm quantity determination of pre - shaped gm water - soluble nitrogen water - soluble phosphorus pentoxide water - soluble potassium oxide ### permissible tolerances for the declared parameter ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the distribution chain ± 0 , 7 at the time of manufacture ± 1 , 0 at any time in the distribution chain - 5% relative deviation at the time of manufacture - 25% relative deviation at any time in the distribution chain - 5% relative deviation at the time of manufacture - 25% relative deviation at any time in the distribution chain - 5% relative deviation at the time of manufacture - 25% relative deviation at any time in the distribution chain ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the distribution chain ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the distribution chain ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the distribution chain permissible tolerances for the declared parameter ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the manufacturing chain ± 0 , 7 at the time of manufacture ± 1 , 0 at any time in the manufacturing chain - 5% relative deviation at the time of manufacture - 25% relative deviation at any time in the manufacturing chain - 5% relative deviation at the time of manufacture - 25% relative deviation at any time in the manufacturing chain - 5% relative deviation at the time of manufacture - 25% relative deviation at any time in the manufacturing chain ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the manufacturing chain ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the manufacturing chain ± 50% relative deviation at the time of manufacture ± 75% relative deviation at any time in the manufacturing chain


### an inorganic macronutrient fertiliser shall be aimed at providing plants with one or more of the following macronutrients : nitrogen , phosphorus , potassium , magnesium , calcium , sulphur or sodium . ### an mineral macronutrient fertiliser shall be aimed at providing plants with one or more of the following macronutrients : primary : nitrogen , phosphorus , and potassium . secondary : magnesium , calcium , sulphur or sodium . the declarable nitrogen content is given by the sum of ammoniacal n , nitric n , ureic n , n from urea formaldehyde , n from isobutylidene diurea , n from crotonylidene diurea . the declarable primary and secondary content is given by the p2o5 , k2o , mgo , cao , so3 , and na2o form . new forms can be added after a scientific examination .


### where the market surveillance authorities of one member state have sufficient reason to believe that a ce marked fertilising product presents an unacceptable risk to human , animal or plant health , to safety or to the environment , they shall carry out an evaluation in relation to the fertilising product concerned covering the requirements laid down in this regulation . the relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose . ### where the market surveillance authorities of one member state have sufficient reason to believe that a ce marked fertilising product presents a risk to human , animal or plant health , to safety or to the environment , they shall carry out an evaluation in relation to the fertilising product concerned covering all relevant requirements laid down in this regulation . the relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose .


### the ce marked fertilising product shall contain one of the following declared nutrients in the minimum quantity stated : ### the ce marked fertilising product shall contain one of the primary declared nutrients in the minimum quantity stated :


### a straight liquid inorganic macronutrient fertiliser shall have a declared content of not more than one nutrient . ### a straight liquid mineral macronutrient fertiliser shall have a declared content of one primary nutrient .


### importers shall indicate their name , registered trade name or registered trade mark and the postal address at which they can be contacted on the packaging of the ce marked fertilising product or , where the ce marked fertilising product is supplied without packaging , in a document accompanying the fertilising product . the contact details shall be in a language easily understood by end - users and market surveillance authorities . ### importers shall indicate their name , registered trade name or registered trade mark , the foreign manufacturer and the country of origin and the postal address at which they can be contacted on the packaging of the ce marked fertilising product or , where the ce marked fertilising product is supplied without packaging , in a document accompanying the fertilising product . the contact details shall be in a language easily understood by end - users and market surveillance authorities .


### it shall apply from 1 january 2018 . ### it shall apply from … [ two years after the date of entry into force of this regulation ] , with the exception of article 13 , articles 19 to 35 and article 41 , which shall apply from … [ nine months after the date of entry into force of this regulation ] and articles 42 , 43 and 45 , which shall apply from … [ the date of entry into force of this regulation ] .


### an inorganic fertiliser shall be a fertiliser other than an organic or organo - mineral fertiliser . ### a mineral fertiliser shall be a fertiliser containing nutrients in a mineral form or processed into a mineral form . calcium cyanamide , urea and its condensation and association products shall be considered as containing nutrients in a mineral form .


### powder , where at least 90% of the product can pass through a sieve with a mesh of 10 mm , or ### powder , where at least 90% of the product can pass through a sieve with a mesh of 1 mm , or


### manufacturers shall ensure that ce marked fertilising products are labelled in accordance with annex iii , or where the fertilising product is supplied without packaging , that the labelling statements are provided in a document accompanying the fertilising product and accessible for inspection purposes when the product is placed on the market . the labelling statement shall be in a language which can be easily understood by end - users , as determined by the member state concerned , and shall be clear , understandable and intelligible . ### manufacturers shall ensure that ce marked fertilising products are labelled in accordance with annex iii . where the fertilising product is supplied in a package the information shall appear on a label , which is affixed to the package . however , where the package is too small to contain all the information , some information shall be provided in a separate leaflet accompanying the package . such a leaflet shall be regarded as part of the label . where the fertilising product is supplied without packaging , all information shall be provided in such a leaflet . the information shall be in a language which can be easily understood by end - users , as determined by the member state concerned , and shall be clear , understandable and intelligible .


### the commission shall be empowered to adopt delegated acts in accordance with article 43 to amend annexes i to iv for the purposes of adapting them to technical progress and facilitating internal market access and free movement for ce marked fertilising products . ### the commission shall be empowered to adopt delegated acts in accordance with article 43 to amend annexes i to iv for the purposes of adapting them to technical progress , in particular as regards the production of fertilisers from animal by - products and waste recovery products or which are used by manufacturers as by - products from or co - products of other industrial and / or agricultural processes , as well as recycled products , taking into account products and materials that have already been authorised in member states , and for the facilitation of internal market access and free movement for ce marked fertilising products :


### –0 , 75% by mass of total calcium oxide , ### –2% by mass of total calcium oxide ,


### for certain recovered wastes within the meaning of directive 2008 / 98 / ec of the european parliament and of the council20 , a market demand for their use as fertilising products has been identified . furthermore , certain requirements are necessary for the waste used as input in the recovery operation and for the treatment processes and techniques , as well as for fertilising products resulting from the recovery operation , in order to ensure that the use of those products does not lead to overall adverse environmental or human health impacts . for ce marked fertilising products , those requirements should be laid down in this regulation . therefore , as of the moment of compliance with all the requirements of this regulation , such products should cease to be regarded as waste within the meaning of directive 2008 / 98 / ec . __________________ 20 directive 2008 / 98 / ec of the european parliament and of the council on waste and repealing certain directives . ### for certain recovered wastes , such as struvite , biochar and ash - based products , within the meaning of directive 2008 / 98 / ec of the european parliament and of the council20 , a market demand for their use as fertilising products has been identified . furthermore , certain requirements are necessary for the waste used as input in the recovery operation and for the treatment processes and techniques , as well as for fertilising products resulting from the recovery operation , in order to ensure that the use of those products does not lead to overall adverse environmental or human health impacts . for ce marked fertilising products , those requirements should be laid down in this regulation . therefore , as of the moment of compliance with all the requirements of this regulation , such products should cease to be regarded as waste within the meaning of directive 2008 / 98 / ec . in order to take advantage of the technical developments and to further incentivise innovation in the recovery of valuable waste streams , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union to add or expand the relevant component material categories , so as to include more recovered waste eligible for use in the production of ce - marked fertilising products , such as struvite , biochar and ash - based products . the proper assessment and setting of processing requirements should start immediately after the entry into force of this regulation . __________________ 20 directive 2008 / 98 / ec of the european parliament and of the council on waste and repealing certain directives .


### –3% by mass of total potassium oxide , ### –5% by mass of total potassium oxide , and can contain one or more secondary nutrients in the minimum quantity stated :


### certain substances , mixtures and micro - organisms , commonly referred to as plant biostimulants , are not as such nutrients , but nevertheless stimulate plants ' nutrition processes . where such products aim solely at improving the plants ' nutrient use efficiency , tolerance to abiotic stress , or crop quality traits , they are by nature more similar to fertilising products than to most categories of plant protection products . such products should therefore be eligible for ce marking under this regulation and excluded from the scope of regulation no 1107 / 2009 of the european parliament and of the council21 regulation no 1107 / 2009 should therefore be amended accordingly . _________________ 21 regulation no 1107 / 2009 of the european parliament and of the council of 21 october 2009 concerning the placing of plant protection products on the market and repealing council directives 79 / 117 / eec and 91 / 414 / eec . ### certain substances , micro - organisms and mixtures thereof , commonly referred to as plant biostimulants , are not necessarily nutrients , but nevertheless stimulate plants ' general vigour and nutrition processes . where such products aim solely at improving the plants ' nutrient use efficiency , nutrient availability tolerance to abiotic stress , plant quality traits , degradation of soil organic matter , or at increasing the availability of confined nutrients in the soil or the rhizosphere , or yield , they are by nature more similar to fertilising products than to most categories of plant protection products . such products should therefore be eligible for ce marking under this regulation and excluded from the scope of regulation no 1107 / 2009 of the european parliament and of the council21 . regulation no 1107 / 2009 should therefore be amended accordingly . _________________ 21 regulation no 1107 / 2009 of the european parliament and of the council of 21 october 2009 concerning the placing of plant protection products on the market and repealing council directives 79 / 117 / eec and 91 / 414 / eec .


### an inorganic macronutrient fertiliser shall be aimed at providing plants with one or more of the following macronutrients : nitrogen , phosphorus , potassium , magnesium , calcium , sulphur or sodium . ### an inorganic macronutrient fertiliser shall be aimed at providing plants with one or more of the following macronutrients : primary : nitrogen , phosphorus , and potassium . secondary : magnesium , calcium , sulphur or sodium . the declarable nitrogen content is given by the sum of ammoniacal n , nitric n , ureic n , n from urea formaldehyde , n from isobutylidene diurea , n from crotonylidene diurea . the declarable primary and secondary content is given by the p2o5 , k2o , mgo , cao , so3 , and na2o form . new forms can be added after a scientific examination .


### - lead 150 mg / kg dry matter . ### - lead 20 mg / kg dry matter .


### proposal for a regulation of the european parliament and of the council laying down rules on the making available on the market of ce marked fertilising products and amending regulations no 1069 / 2009 and no 1107 / 2009 ### proposal for a regulation of the european parliament and of the council laying down rules on the making available on the market of ce marked fertilisers and improving nutrition efficiency products and amending regulations no 1069 / 2009 , no 1107 / 2009 and no 1907 / 2006


### a ce marked fertilising product that has undergone a recovery operation and complies with the requirements laid down in this regulation shall be considered to comply with the conditions laid down in article 6 of directive 2008 / 98 / ec and shall , therefore , be considered as having ceased to be waste . ### a material that has undergone a recovery operation and complies with the requirements laid down in this regulation and has demonstrated agronomic efficacy shall be considered to be a component material of a ce marked fertilising product that complies with the conditions laid down in article 6 of directive 2008 / 98 / ec and shall , therefore , be considered to have ceased being waste .


### before making a ce marked fertilising product available on the market distributors shall verify that it is accompanied by the eu declaration of conformity and by the required documents , that it is labelled in accordance with annex iii in a language which can be easily understood by end - users in the member state in which the ce marked fertilising product is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 6 and and article 8 respectively . ### before making a ce marked fertilising product available on the market distributors shall verify that it is accompanied by the required documents , that it is labelled in accordance with annex iii in a language which can be easily understood by end - users in the member state in which the ce marked fertilising product is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 6 and and article 8 respectively . where the ce marked fertilising product is supplied without packaging , market distributors shall verify that the required information is provided in a documents accompanying the ce marked fertilising product . that information shall also be in a language which can be easily understood by end - users in the member state in which the ce marked fertilising product is to be made available on the market .


### products complying with all the requirements of this regulation should be allowed to move freely on the internal market . where one or more of the component materials in a ce marked fertilising product falls within the scope of regulation no 1069 / 2009 of the european parliament and of the council18 , but reaches a point in the manufacturing chain beyond which it no longer poses any significant risk to public or animal health , it would represent an unnecessary administrative burden to continue subjecting the product to the provisions of that regulation . such fertilising products should therefore be excluded from the requirements of that regulation . regulation no 1069 / 2009 should therefore be amended accordingly . __________________ 18 regulation no 1069 / 2009 of the european parliament and of the council of 21 october 2009 laying down health rules as regards animal by - products and derived products not intended for human consumption and repealing regulation no 1774 / 2002 . ### ce marked fertilising products complying with all the requirements of this regulation should be allowed to move freely on the internal market . where one or more of the component materials is a derived product within the scope of regulation no 1069 / 2009 of the european parliament and of the council18 , but has reached a point in the manufacturing chain beyond which it no longer poses any significant risk to public or animal health , it would represent an unnecessary administrative burden to continue subjecting the product to the provisions of that regulation . such fertilising products should therefore be excluded from the requirements of that regulation . regulation no 1069 / 2009 should therefore be amended accordingly . __________________ 18 regulation no 1069 / 2009 of the european parliament and of the council of 21 october 2009 laying down health rules as regards animal by - products and derived products not intended for human consumption and repealing regulation no 1774 / 2002 .


### an inorganic macronutrient fertiliser shall be aimed at providing plants with one or more of the following macronutrients : nitrogen , phosphorus , potassium , magnesium , calcium , sulphur or sodium . ### an mineral macronutrient fertiliser shall be aimed at providing plants with one or more of the following macronutrients : primary : nitrogen , phosphorus , and potassium . secondary : magnesium , calcium , sulphur or sodium . the declarable nitrogen content is given by the sum of ammoniacal n , nitric n , ureic n , n from urea formaldehyde , n from isobutylidene diurea , n from crotonylidene diurea . the declarable primary and secondary content is given by the p2o5 , k2o , mgo , cao , so3 , and na2o form . new forms can be added after a scientific examination .


### importers shall , for 10 years after the ce marked fertilising product has been placed on the market , keep a copy of the eu declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities , upon request . ### importers shall , for five years after the ce marked fertilising product has been placed on the market , keep a copy of the eu declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities , upon request . on request , importers shall make a copy of the eu declaration of conformity available to other economic operators concerned .


### a soil improver shall be a ce marked fertilising product aimed at being added to the soil for the purpose of maintaining , improving or protecting the physical or chemical properties , the structure or the biological activity of soil . ### a soil improver shall be a material added to soil in situ primarily to maintain or improve its physical properties , and which may improve its chemical and / or biological properties or activity .


### a growing medium shall be a material other than soil intended for use as a substrate for root development . ### a growing medium shall be a material other than soil in situ in which plants and mushrooms are grown .


### - 5% by mass of total sulphur trioxide , or ### - 5% by mass of total sulphur trioxide ,


### ' 34 . ' plant biostimulant ' means a product stimulating plant nutrition processes independently of the product ' s nutrient content with the sole aim of improving one or more of the following characteristics of the plant : ### ' 34 . ' plant biostimulant ' means a product containing any substance or micro - organism stimulating plant nutrition processes independently of its nutrient content , or any combination of such substances and / or micro - organisms , with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere :


### taxonomic relation to micro - organism species fulfilling the requirements for a qualified presumption of safety as established by the european food safety agency ; ### taxonomic relation to micro - organism species fulfilling the requirements for a qualified presumption of safety as established by the european food safety authority ;


### polymers , or ### polymers with the exception of those used in growing media not in contact with the soil , or


### the existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to ce marked fertilising products presenting an unacceptable risk to human , animal or plant health , to safety or to the environment . it should also allow market surveillance authorities , in cooperation with the relevant economic operators , to act at an early stage in respect of such fertilising products . ### the existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to ce marked fertilising products presenting a risk to human , animal or plant health , to safety or to the environment . it should also allow market surveillance authorities , in cooperation with the relevant economic operators , to act at an early stage in respect of such fertilising products .


### when placing a ce marked fertilising product on the market , the importer should indicate on the packaging of the fertilising product his or her name , registered trade name or registered trade mark and the postal address at which he or she can be contacted , in order to enable market surveillance . ### when placing a ce marked product on the market , the importer should indicate on the packaging of the product his or her name , registered trade name or registered trade mark and the postal address at which he or she can be contacted , as well as the foreign manufacturer and the country of origin of the product in order to enable market surveillance .


### a compound liquid inorganic macronutrient fertiliser shall have a declared content of more than one nutrient . ### a compound liquid inorganic macronutrient fertiliser shall have a declared content of more than one primary nutrient .


### before placing a ce marked fertilising product on the market importers shall ensure that the appropriate conformity assessment procedure referred to in article 14 has been carried out by the manufacturer . they shall ensure that the manufacturer has drawn up the technical documentation , that the ce marked fertilising product is accompanied by the eu declaration of conformity and the required documents , and that the manufacturer has complied with the requirements set out in article 6 and . where an importer considers or has reason to believe that a ce marked fertilising product is not in conformity with the applicable requirements set out in annex i , annex ii or annex iii , he or she shall not place the fertilising product on the market until it has been brought into conformity . furthermore , where the ce marked fertilising product presents an unacceptable risk to human , animal or plant health , to safety or to the environment , the importer shall inform the manufacturer and the market surveillance authorities to that effect . ### before placing a ce marked fertilising product on the market importers shall ensure that the appropriate conformity assessment procedure referred to in article 14 has been carried out by the manufacturer . they shall ensure that the manufacturer has drawn up the technical documentation , that the ce marked fertilising product is accompanied by the eu declaration of conformity and the required documents , and that the manufacturer has complied with the requirements set out in article 6 and . where an importer considers or has reason to believe that a ce marked fertilising product is not in conformity with the applicable requirements of this regulation , he or she shall not place the fertilising product on the market until it has been brought into conformity . furthermore , where the ce marked fertilising product presents an unacceptable risk to human , animal or plant health , to safety or to the environment , the importer shall inform the manufacturer and the market surveillance authorities to that effect .


### a ce marked fertilising product that has undergone a recovery operation and complies with the requirements laid down in this regulation shall be considered to comply with the conditions laid down in article 6 of directive 2008 / 98 / ec and shall , therefore , be considered as having ceased to be waste . ### where a material that was waste has undergone a recovery operation in accordance with this regulation and a compliant ce marked fertilising product contains or consists of that material , the material shall be considered to comply with the conditions laid down in article 6 of directive 2008 / 98 / ec and shall , therefore , be considered as having ceased to be waste from the moment the union declaration of conformity is drawn up .


### ce - marked fertilising products should be placed on the market only if they are sufficiently effective and do not present unacceptable risks to human , animal or plant health , to safety or to the environment when properly stored and used for their intended purpose , and under conditions of use which can be reasonably foreseen , that is when such use could result from lawful and readily predictable human behaviour . therefore , requirements for safety and quality , as well as appropriate control mechanisms , should be established . furthermore , the intended use of ce marked fertilising products should not lead to food or feed becoming unsafe . ### ce - marked fertilising products should be placed on the market only if they are sufficiently effective and do not present risks to human , animal or plant health , to safety or to the environment when properly stored and used for their intended purpose , and under conditions of use which can be reasonably foreseen , that is when such use could result from lawful and readily predictable human behaviour . therefore , requirements for safety and quality , as well as appropriate control mechanisms , should be established .


### before making a ce marked fertilising product available on the market distributors shall verify that it is accompanied by the eu declaration of conformity and by the required documents , that it is labelled in accordance with annex iii in a language which can be easily understood by end - users in the member state in which the ce marked fertilising product is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 6 and and article 8 respectively . ### before making a ce marked fertilising product available on the market distributors shall verify that it is accompanied by the required documents , that it is labelled in accordance with annex iii in a language which can be easily understood by end - users in the member state in which the ce marked fertilising product is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 6 and and article 8 respectively . where the ce marked fertilising product is supplied without packaging , market distributors shall verify that the required information is provided in a document accompanying the ce marked fertilising product . that information shall also be in a language which can be easily understood by end - users in the member state in which the ce marked fertilising product is to be made available on the market .


### a ce marked fertilising product may contain compost obtained through aerobic composting of exclusively one or more of the following input materials : ### a eu fertilising product may contain compost , a liquid or non - liquid microbial or non - microbial extract made out of compost , obtained through aerobic composting , and the possible ensuing multiplication of the naturally occurring microbials of exclusively one or more of the following input materials :


### a blend of different ce marked fertilising products , each of which has been subject to a successful assessment of conformity with the applicable requirements for that material , can itself be expected to be suitable for use as a ce marked fertilising product , subject only to certain additional requirements warranted by the blending . therefore , in order to avoid an unnecessary administrative burden , such blends should belong to a separate category , for which the conformity assessment should be limited to the additional requirements warranted by the blending . ### a combination of different ce marked fertilising products , each of which has been subject to a successful assessment of conformity with the applicable requirements for that material , can itself be expected to be suitable for use as a ce marked fertilising product , subject only to certain additional requirements warranted by the mixing . therefore , in order to avoid an unnecessary administrative burden , such combinations should belong to a separate category , for which the conformity assessment should be limited to the additional requirements warranted by the mixing .


### the end point in the manufacturing chain should be determined for each relevant component material containing animal by - products in accordance with the procedures laid down in regulation no 1069 / 2009 . where a manufacturing process regulated under this regulation starts already before that end point has been reached , the process requirements of both regulation no 1069 / 2009 and this regulation should apply cumulatively to ce marked fertilising products , which means application of the stricter requirement in case both regulations regulate the same parameter . ### for each component material category which includes derived products within the meaning of regulation no 1069 / 2009 , the end point in the manufacturing chain should be determined for each relevant component material containing animal by - products in accordance with the procedures laid down in that regulation . where such an end point is reached before the ce marked fertilising product is placed on the market but after the manufacturing process regulated under this regulation has started , the process requirements of both regulation no 1069 / 2009 and this regulation should apply cumulatively to ce marked fertilising products , which means application of the stricter requirement in case both regulations regulate the same parameter .


### manufacturers shall keep the technical documentation and the eu declaration of conformity for 10 years after the ce marked fertilising product covered by those documents has been placed on the market . ### manufacturers shall keep the technical documentation and the eu declaration of conformity for five years after the ce marked fertilising product covered by those documents has been placed on the market .


### –where soft ground phosphate is present , phosphorous pentoxide soluble in formic acid ; ### –phosphorus pentoxide only soluble in mineral acids ;


### as of [ publications office , please insert the date occurring three years after the date of application of this regulation ] , the following criterion shall be complied with : the polymer shall be capable of undergoing physical , biological decomposition , such that most of it ultimately decomposes into carbon dioxide , biomass and water . it shall have at least 90 % of the organic carbon converted into co2 in maximum 24 months , in a biodegradability test as specified points - below . the test shall be conducted at 25&#176 ; c &#177 ; 2&#176 ; c . the test shall be conducted in accordance with a method for determining the ultimate aerobic biodegradability of plastic materials in soils by measuring oxygen demand or the amount of carbon dioxide evolved . a micro - crystalline cellulose powder with the same dimension as the test material shall be used as a reference material in the test . prior to the test , the test material shall not be subject to conditions or procedures designed to accelerate the degradation of the film , such as exposure to heat or light . ### as of [ publications office , please insert the date occurring five years after the date of application of this regulation ] , the commission shall adopt delegated acts , pursuant to article 42 of this regulation , introducing : a standard for the biodegradability by setting a timeframe in which at least 90 % of the organic carbon is converted into co2 , after the claimed release time of the polymer has been fulfilled , and a biodegradability test that complies with the following criterion : the polymer is capable of undergoing physical , biological decomposition , such that most of it ultimately decomposes into carbon dioxide , biomass and water .


### products complying with all the requirements of this regulation should be allowed to move freely on the internal market . where one or more of the component materials in a ce marked fertilising product falls within the scope of regulation no 1069 / 2009 of the european parliament and of the council18 , but reaches a point in the manufacturing chain beyond which it no longer poses any significant risk to public or animal health , it would represent an unnecessary administrative burden to continue subjecting the product to the provisions of that regulation . such fertilising products should therefore be excluded from the requirements of that regulation . regulation no 1069 / 2009 should therefore be amended accordingly . __________________ 18 regulation no 1069 / 2009 of the european parliament and of the council of 21 october 2009 laying down health rules as regards animal by - products and derived products not intended for human consumption and repealing regulation no 1774 / 2002 . ### ce marked fertilising products complying with all the requirements of this regulation should be allowed to move freely on the internal market . where one or more of the component materials is a derived product within the scope of regulation no 1069 / 2009 of the european parliament and of the council18 , but has reached a point in the manufacturing chain beyond which it no longer poses any significant risk to public or animal health , it would represent an unnecessary administrative burden to continue subjecting the product to the provisions of that regulation . such fertilising products should therefore be excluded from the requirements of that regulation . regulation no 1069 / 2009 should therefore be amended accordingly . __________________ 18 regulation no 1069 / 2009 of the european parliament and of the council of 21 october 2009 laying down health rules as regards animal by - products and derived products not intended for human consumption and repealing regulation no 1774 / 2002 .


### the polymers shall not contain formaldehyde . ### the polymers shall not contain free formaldehyde .


### a straight solid inorganic macronutrient fertiliser shall have a declared content of not more than one nutrient . ### a straight solid mineral macronutrient fertiliser shall have a declared content of one primary nutrient .


### the nitrification inhibitor content shall be expressed as a percentage by mass of the total nitrogen present as ammonium nitrogen and urea nitrogen . ### the nitrification inhibitor content shall be expressed as a percentage by mass of the total nitrogen present as ammonium nitrogen or ammonium nitrogen and urea nitrogen .


### where a distributor considers or has reason to believe that a ce marked fertilising product is not in conformity with the applicable requirements set out in annex i , annex ii or annex iii , he or she shall not make the fertilising product available on the market until it has been brought into conformity . furthermore , where the ce marked fertilising product presents an unacceptable risk to human , animal or plant health , to safety or to the environment , the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities . ### where a distributor considers or has reason to believe that a ce marked fertilising product is not in conformity with the applicable requirements of this regulation , he or she shall not make the fertilising product available on the market until it has been brought into conformity . furthermore , where the ce marked fertilising product presents an unacceptable risk to human , animal or plant health , to safety or to the environment , the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities .


### as of [ publications office , please insert the date occurring three years after the date of application of this regulation ] , the following criterion shall be complied with : the polymer shall be capable of undergoing physical , biological decomposition , such that most of it ultimately decomposes into carbon dioxide , biomass and water . it shall have at least 90 % of the organic carbon converted into co2 in maximum 24 months , in a biodegradability test as specified points - below . ### as of [ publications office , please insert the date occurring five years after the date of application of this regulation ] , the following criterion shall be complied with : the polymer shall be capable of undergoing physical , biological decomposition , such that most of it ultimately decomposes into carbon dioxide , biomass and water . it shall have at least 90 % of the organic carbon converted into co2 compared to an appropriate standard in the biodegradation test . in order to meet this criterion the biodegradability criteria and the development of an appropriate testing method for biodegradation shall be evaluated in the light of the latest scientific evidenceand set in delegated acts adopted in accordance with articles 42 of this regulation .


### - 0 , 75% by mass of total magnesium oxide , ### - 1 , 5% by mass of total magnesium oxide , or


### a compound liquid inorganic macronutrient fertiliser shall have a declared content of more than one nutrient . ### a compound liquid inorganic macronutrient fertiliser shall have a declared content of more than one primary nutrient .


### ●total phosphorus pentoxide ; ### ●phosphorus pentoxide soluble in neutral ammonium citrate and water


### the ce marking shall be affixed visibly , legibly and indelibly to the accompanying documents and , where the ce marked fertilising product is supplied in a packaged form , to the packaging . ### the ce marking shall be affixed visibly , legibly and indelibly to the packaging of the ce marked fertilising product or , where the ce marked fertilising product is supplied without packaging , in a document accompanying the ce marked fertilising product .


### –organic carbon ; and ### –organic carbon and c / n ratio ;


### for the purpose of paragraph 1 , plants are understood to include algae and exclude blue - green algae . ### for the purpose of paragraph 1 , plants are understood to include algae except for blue - green algae that produce cyanotoxins classified as hazardous in accordance with regulation no 1272 / 2008 on classification , labelling and packaging of substances and mixtures .


### ' fertilising product ' means a substance , mixture , micro - organism or any other material , applied or intended to be applied , either on its own or mixed with another material , on plants or their rhizosphere for the purpose of providing plants with nutrient or improving their nutrition efficiency ; ### ' fertilising product ' means a substance , mixture , micro - organism or any other material applied or intended to be applied , either on its own or mixed with another material , on fungi or their mycosphere or on plants at any growth stage , including seeds , and / or rhizosphere , for the purpose of providing plants or fungi with nutrients or of improving their physical or biological growth conditions or their general vigour , yields and quality by enhancing their nutrition efficiency , including by increasing the ability of the plant to take up nutrients from the phyllosphere no 1107 / 2009 ) .


### where , having carried out an evaluation under article 37 , a member state finds that although a ce marked fertilising product is in compliance with this regulation it presents an unacceptable risk to human , animal or plant health , to safety or to the environment , it shall require the relevant economic operator to take all appropriate measures within a reasonable period to ensure that the fertilising product concerned , when placed on the market , no longer presents that risk , to withdraw the fertilising product from the market or to recall it . ### where , having carried out an evaluation under article 37 , a member state finds that although a ce marked fertilising product is in compliance with this regulation it presents an unacceptable risk to human , animal or plant health , to safety or to the environment , it shall require the relevant economic operator to take all appropriate measures within a reasonable period to ensure that the fertilising product concerned , when made available on the market , no longer presents that risk , to withdraw the fertilising product from the market or to recall it .


### an inorganic fertiliser shall be a fertiliser other than an organic or organo - mineral fertiliser . ### a mineral fertiliser shall be a fertiliser containing nutrients in a mineral form or processed into a mineral form from animal or plant origin . urea and its condensation and association products shall be considered as containing nutrients in a mineral form .


### an agronomic additive shall be a ce marked fertilising product intended to be added to a product providing plants with nutrient , with the intention to improve that product ' s nutrient release patterns . ### an agronomic additive shall be a ce marked fertilising product intended to be added to a product , which has a proven effect on the transformation or plant - availability of different forms of mineral or mineralized nutrients , or both , or which is to be added to the soil with the intention to improve that nutrient uptake by plants or to reduce nutrient losses .


### - 1 , 5% by mass of total sulphur trioxide , or ### - 5% by mass of total sulphur trioxide ,


### a ce marked fertilising product that has undergone a recovery operation and complies with the requirements laid down in this regulation shall be considered to comply with the conditions laid down in article 6 of directive 2008 / 98 / ec and shall , therefore , be considered as having ceased to be waste . ### where a material that was waste has undergone a recovery operation in accordance with this regulation and a compliant ce marked fertilising product contains or consists of that material , the material shall be considered to comply with the conditions laid down in article 6 of directive 2008 / 98 / ec and shall , therefore , be considered as having ceased to be waste from the moment the union declaration of conformity is drawn up .


### - carbon and ### - organic carbon and


### a description of all components above 5% by product weight in descending order of magnitude by dry weight , including an indication of the relevant component material categories as referred to in annex ii . ### a description of all components above 1% by product weight in descending order of magnitude by dry weight , including an indication of the relevant component material categories as referred to in annex ii and including the content as percentage by the dry matter ;


### where the commission amends annex ii in order to add new micro - organisms to the component material category for such organisms pursuant to paragraph 1 , it shall do so on the basis of the following data : ### where the commission amends annex ii in order to add new micro - organisms to the component material category for such organisms , it shall do so , after verifying that all strains of the additional microorganism comply with the requirements in paragraph 1 of this article , on the basis of the following data :


### the ce marking shall be affixed visibly , legibly and indelibly to the accompanying documents and , where the ce marked fertilising product is supplied in a packaged form , to the packaging . ### the ce marking shall be affixed visibly , legibly and indelibly to the packaging of the ce marked fertilising product or , where the ce marked fertilising product is supplied without packaging , to the documents accompanying the ce marked fertilising product .


### a soil improver shall be a ce marked fertilising product aimed at being added to the soil for the purpose of maintaining , improving or protecting the physical or chemical properties , the structure or the biological activity of soil . ### a soil improver shall be a material added to soil in situ primarily to maintain or improve its physical properties , and which may improve its chemical and / or biological properties or activity .


### ' 34 . ' plant biostimulant ' means a product stimulating plant nutrition processes independently of the product ' s nutrient content with the sole aim of improving one or more of the following characteristics of the plant : ### ' 34 . ' plant biostimulant ' means a product containing any substance or micro - organism stimulating plant nutrition processes independently of its nutrient content , or any combination of such substances and / or micro - organisms , with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere :


### a ce marked fertilising product that has undergone a recovery operation and complies with the requirements laid down in this regulation shall be considered to comply with the conditions laid down in article 6 of directive 2008 / 98 / ec and shall , therefore , be considered as having ceased to be waste . ### a material that has undergone a recovery operation and complies with the requirements laid down in this regulation shall be considered to be a component material of a ce marked fertilising product that complies with the conditions laid down in article 6 of directive 2008 / 98 / ec and shall , therefore , be considered to have ceased being waste . this component material may fall under the scope of this regulation if it demonstrates an agronomic efficacy and if it meets the requirements laid down in the annexes of this regulation .


### without prejudice to the common specifications referred to in article 13 , ce marked fertilising products which are in conformity with harmonised standards or parts thereof the references of which have been published in the official journal of the european union shall be presumed to be in conformity with the requirements set out in annexes i , ii and iii covered by those standards or parts thereof . ### ce marked fertilising products which are in conformity with , or have been tested in conformity with harmonised standards or parts thereof the references of which have been published in the official journal of the european union shall be presumed to be in conformity with the respective requirements set out in annexes i , ii and iii covered by those standards or parts thereof .


### a straight liquid inorganic macronutrient fertiliser shall have a declared content of not more than one nutrient . ### a straight liquid mineral macronutrient fertiliser shall have a declared content of one primary nutrient .


### promising technical progress is being made in the field of recycling of waste , such as phosphorus recycling from sewage sludge , and fertilising product production from animal by - products , such as biochar . it should be possible for products containing or consisting of such materials to access the internal market without unnecessary delay when the manufacturing processes have been scientifically analysed and process requirements have been established at union level . for that purpose , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of defining larger or additional categories of ce marked fertilising products or component materials eligible for use in the production of such products . for animal by - products , component material categories should be expanded or added only to the extent an end point in the manufacturing chain has been determined in accordance with the procedures laid down in regulation no 1069 / 2009 , since animal by - products for which no such end point has been determined are in any event excluded from the scope of this regulation . ### promising technical progress is being made in the field of recycling of waste , such as phosphorus recycling from sewage sludge , and fertilising product production from animal by - products , such as biochar . it should be possible for products containing or consisting of such materials to access the internal market without unnecessary delay when the manufacturing processes have been scientifically analysed and process requirements have been established at union level . for that purpose , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the eligibility of such materials for use in production . for products derived from animal by - products , component material categories should be expanded or added only to the extent an end point in the manufacturing chain has been determined in accordance with the procedures laid down in regulation no 1069 / 2009 , since animal by - products for which no such end point has been determined are in any event excluded from the scope of this regulation .


### products with one or more functions , one of which is covered by the scope of regulation no 1107 / 2009 , should remain under the control tailored for such products and provided for by that regulation . where such products also have the function of a fertilising product , it would be misleading to provide for their ce marking under this regulation , since the making available on the market of a plant protection product is contingent on a product authorisation valid in the member state in question . therefore , such products should be excluded from the scope of this regulation . ### products with one or more functions , one of which is covered by the scope of regulation no 1107 / 2009 , are plant protection products covered by the scope of that regulation . those products should remain under the control tailored for such products and provided for by that regulation . where such products also have the function of a fertilising product , it would be misleading to provide for their ce marking under this regulation , since the making available on the market of a plant protection product is contingent on a product authorisation valid in the member state in question . therefore , such products should be excluded from the scope of this regulation .


### - 0 , 75% by mass of total calcium oxide , ### - 1 , 5% by mass of total calcium oxide , or


### ce - marked fertilising products should be placed on the market only if they are sufficiently effective and do not present unacceptable risks to human , animal or plant health , to safety or to the environment when properly stored and used for their intended purpose , and under conditions of use which can be reasonably foreseen , that is when such use could result from lawful and readily predictable human behaviour . therefore , requirements for safety and quality , as well as appropriate control mechanisms , should be established . furthermore , the intended use of ce marked fertilising products should not lead to food or feed becoming unsafe . ### ce - marked products should be placed on the market only if their agronomic efficacy has been proven and do not present unacceptable risks to human , animal or plant health , to safety or to the environment when properly stored and used for their intended purpose , and under conditions of use which can be reasonably foreseen , that is when such use could result from lawful and readily predictable human behaviour . therefore , requirements for safety and quality , as well as appropriate control mechanisms , should be established . furthermore , the intended use of ce marked products should not lead to food or feed becoming unsafe .


### member states shall not impede the making available on the market of ce marked fertilising products which comply with this regulation . ### member states shall not impede the making available on the market of ce marked fertilising products which comply with this regulation for reasons of composition , labelling or other provisions of this regulation . concerning the use of ce marked fertilising products , member states may maintain or adopt national provisions for the purpose of protecting human health and the environment . however , those provisions shall not require modification of ce marked fertilising products which are in compliance with this regulation . also , those provisions shall not influence the conditions for making them available on the market .


### an inorganic soil improver shall be a soil improver other than an organic soil improver . ### an inorganic soil improver shall be a soil improver other than an organic soil improver , and shall include mulch films . a biodegradable mulch film shall be a biodegradable polymer film complying in particular with the requirements of points 2a and 3 of cmc 10 in annex ii and intended to be placed on the soil in situ to protect its structure , suppress weed growth , reduce soil moisture loss , or prevent erosion .


### when placing a ce marked fertilising product on the market , the importer should indicate on the packaging of the fertilising product his or her name , registered trade name or registered trade mark and the postal address at which he or she can be contacted , in order to enable market surveillance . ### when placing a ce marked product on the market , the importer should indicate on the packaging of the product his or her name , registered trade name or registered trade mark and the postal address at which he or she can be contacted , as well as the foreign manufacturer and the country of origin of the product in order to enable market surveillance .


### the commission shall be empowered to adopt delegated acts in accordance with article 43 to amend annexes i to iv for the purposes of adapting them to technical progress and facilitating internal market access and free movement for ce marked fertilising products . ### the commission shall be empowered to adopt delegated acts in accordance with article 43 to amend annexes i to iv for the purposes of adapting them to technical progress , in particular as regards the production of fertilisers from animal by - products and waste recovery products or which are used by manufacturers as by - products from or co - products of other industrial and / or agricultural processes , as well as recycled products , taking into account products and materials that have already been authorised in member states , and for the facilitation of internal market access and free movement for ce marked fertilising products :


### a ce marked fertilising product may contain compost obtained through aerobic composting of exclusively one or more of the following input materials : ### a eu fertilising product may contain compost , a liquid or non - liquid microbial or non - microbial extract made out of compost , obtained through aerobic composting , and the possible ensuing multiplication of the naturally occurring microbials of exclusively one or more of the following input materials :


### a straight solid inorganic macronutrient fertiliser shall have a declared content of not more than one nutrient . ### a straight solid mineral macronutrient fertiliser shall have a declared content of not more than one primary nutrient , phosphorus , and potassium ) .


### manufacturers shall ensure that ce marked fertilising products are labelled in accordance with annex iii , or where the fertilising product is supplied without packaging , that the labelling statements are provided in a document accompanying the fertilising product and accessible for inspection purposes when the product is placed on the market . the labelling statement shall be in a language which can be easily understood by end - users , as determined by the member state concerned , and shall be clear , understandable and intelligible . ### manufacturers shall ensure that ce marked fertilising products are labelled in accordance with annex iii . where the fertilising product is supplied in a package the information shall appear on a label , which is affixed to the package . however , where the package is too small to contain all the information , some information shall be provided in a separate leaflet accompanying the package . such a leaflet shall be regarded as part of the label . where the fertilising product is supplied without packaging , all information shall be provided in such a leaflet . the information shall be in a language which can be easily understood by end - users , as determined by the member state concerned , and shall be clear , understandable and intelligible .


### for the purpose of paragraph 1 , plants are understood to include algae and exclude blue - green algae . ### for the purpose of paragraph 1 , plants are understood to include algae except for blue - green algae that produce cyanotoxins classified as hazardous in accordance with regulation no 1272 / 2008 on classification , labelling and packaging of substances and mixtures .


### –following five thermal cycles as described under heading 4 . 2 in module a1 in annex iv , ### –following five thermal cycles as described under heading 4 . 2 in module a1 in annex iv , for testing before placing on the market ,


### - 1 , 5% by mass of total nitrogen , ### - 3% by mass of total nitrogen , or


### where the commission amends annex ii in order to add new micro - organisms to the component material category for such organisms pursuant to paragraph 1 , it shall do so on the basis of the following data : ### where the commission amends annex ii in order to add new strains of micro - organisms to the component material category for such organisms pursuant to paragraph 1 , it shall do so on the basis of the following data :


### to ensure an appropriate response of the union in the event of unforeseen circumstances ; ### to ensure an appropriate response of the union in the event of newly arising challenges and unforeseen circumstances ;


### the agency shall , in cooperation with the european border and coast guard agency and the european fisheries control agency , support national authorities carrying out coastguard functions at national and union level , and where appropriate at international level by : sharing information generated by fusing and analysing data available in ship reporting systems and other information systems hosted by or accessible to the agencies , in accordance with their respective legal bases and without prejudice to the ownership of data by member states ; providing surveillance and communication services based on state - of - the - art technology , including space - based and ground infrastructure and sensors mounted on any kind of platform , such as remotely piloted aircraft systems ; capacity building by elaborating guidelines , recommendations and best practices as well as by supporting the training and exchange of staff , with a view to enhancing the exchange of information and cooperation on coastguard functions ; capacity sharing , including the planning and implementation of multipurpose operations and the sharing of assets and other capabilities across sectors and borders . 2 . the modalities of the cooperation on coastguard functions of the agency with the european border and coast guard agency and the european fisheries control agency shall be determined in a working arrangement , in accordance with the financial rules applicable to the agencies . 3 . the commission may adopt , in the form of a recommendation , a practical handbook on european cooperation on coastguard functions , containing guidelines , recommendations and best practices for the exchange of information and cooperation at national , union and international level . ### the agency shall , in cooperation with the european border and coast guard agency and the european fisheries control agency , support national authorities carrying out coastguard functions at national and union level , and where appropriate at international level by : sharing information generated by fusing and analysing data available in ship reporting systems and other information systems hosted by or accessible to the agencies , in accordance with their respective legal bases and without prejudice to the ownership of data by member states ; providing surveillance and communication services based on state - of - the - art technology , including space - based and ground infrastructure and sensors mounted on any kind of platform ; capacity building by elaborating guidelines , recommendations and best practices as well as by providing training and exchange of staff ; enhancing the exchange of information and cooperation on coast guard functions and emerging risks in the maritime domain ; capacity sharing , including the planning and implementation of multipurpose operations and the sharing of assets and other capabilities across sectors and borders . 2 . the modalities of the cooperation on coastguard functions of the agency with the european border and coast guard agency and the european fisheries control agency shall be determined in a working arrangement , in accordance with their respective mandates and the financial rules applicable to the agencies . 3 . the commission may adopt , in the form of a recommendation , a practical handbook on european cooperation on coastguard functions , containing guidelines , recommendations and best practices for the exchange of information and cooperation at national , union and international level .


### member states shall ensure that the maximum amount of the fine a national competition authority may impose on each undertaking or association of undertakings participating in an infringement of articles 101 or 102 tfeu should not be set at a level below 10% of its total worldwide turnover in the business year preceding the decision . ### member states shall ensure that a national competition authority may impose on each undertaking or association of undertakings participating in an infringement of articles 101 or 102 tfeu a maximum fine of not less than 10% of its total worldwide turnover in the business year preceding the decision .


### the staff and the members of the decision - making body of national administrative competition authorities refrain from any action which is incompatible with the performance of their duties and exercise of their powers for the application of articles 101 and 102 tfeu ; ### the director , the staff , the members of the decision - making body and the management of national administrative competition authorities refrain from any action which is incompatible with the performance of their duties and exercise of their powers for the application of articles 101 and 102 tfeu . in particular , that obligation entails that during their employment and their term of office , they do not have an interest in any businesses or organisations that have dealings with a national administrative competition authority to the extent that such interest has the potential to compromise their independence ;


### member states shall ensure that national administrative competition authorities may by decision require undertakings and associations of undertakings to provide all necessary information for the application of articles 101 and 102 tfeu within a specified time limit . this obligation shall cover information which is accessible to the undertaking and association of undertakings . ### member states shall ensure that national administrative competition authorities may by decision require undertakings and associations of undertakings to provide all necessary information for the application of articles 101 and 102 tfeu within a reasonable time limit and insofar as the addressee of the decision does not as a result incriminate itself in respect of an infringement of articles 101 and 102 tfeu . this obligation shall cover information which is in the possession of the undertaking and association of undertakings .


### member states shall ensure that applicants that have applied for leniency , either by applying for a market or by submitting a full application , to the commission in relation to an alleged secret cartel can file summary applications in relation to the same cartel with the national competition authorities which the applicant considers well placed to deal with the case . ### member states shall ensure that applicants that have applied for leniency , either by applying for a marker or by submitting a full application , to the commission in relation to an alleged secret cartel can file summary applications in relation to the same cartel with the national competition authorities which the applicant considers well placed to deal with the case .


### articles 101 and 102 of the treaty on the functioning of the european union are a matter of public policy and should be applied effectively throughout the union to ensure that competition in the internal market is not distorted . effective enforcement of articles 101 and 102 tfeu is necessary to ensure more open competitive markets in europe , where companies compete more on their merits and without company erected barriers to market entry , enabling them to generate wealth and create jobs . it protects consumers from business practices that keep the prices of goods and services artificially high and enhances their choice of innovative goods and services . ### articles 101 and 102 of the treaty on the functioning of the european union are a matter of public policy and should be applied effectively throughout the union to ensure that competition in the internal market is not distorted . effective enforcement of articles 101 and 102 tfeu is necessary to ensure more open and competitive markets in europe , without barriers to market entry , enabling companies to compete on their merits and to generate wealth and create jobs . it protects consumers from business practices that keep the prices of goods and services artificially high and enhances their choice of innovative goods and services .


### the investigative powers of national administrative competition authorities need to be adequate to meet the enforcement challenges of the digital environment and should enable national competition authorities to obtain all information in digital form , including data obtained forensically , related to the undertaking or association of undertakings which is subject to the investigative measure , irrespective of the medium on which it is stored , such as on laptops , mobile phones and other mobile devices . ### the investigative powers of national administrative competition authorities need to be adequate to meet the enforcement challenges of the digital environment and should enable national competition authorities to obtain all information in digital form , including data obtained forensically , related to the undertaking or association of undertakings which is subject to the investigative measure , irrespective of the medium on which it is stored , such as on laptops , mobile phones , other mobile devices and cloud storage .


### they supply incorrect , incomplete or misleading information in response to a request made by a decision referred to by article 8 or do not supply information within the specified time - limit ; ### they supply incorrect , incomplete or misleading information in response to a request referred to in article 8 or do not supply information within the specified time - limit ;


### member states shall ensure that national administrative competition authorities may by decision require undertakings and associations of undertakings to provide all necessary information for the application of articles 101 and 102 tfeu within a specified time limit . this obligation shall cover information which is accessible to the undertaking and association of undertakings . ### member states shall ensure that national administrative competition authorities may require undertakings and associations of undertakings to provide all necessary information for the application of articles 101 and 102 tfeu within a specified time limit . this obligation shall cover information which is accessible to the undertaking and association of undertakings .


### gaps and limitations in ncas ' tools and guarantees undermine the system of parallel powers for the enforcement of articles 101 and 102 tfeu which is designed to work as a cohesive whole based on close cooperation within the european competition network . this system depends on authorities being able to rely on each other to carry out fact - finding measures on each other ' s behalf . however it does not work well when there are still ncas that do not have adequate fact - finding tools . in other key respects , ncas are not able to provide each other with mutual assistance . for example , in the majority of member states , undertakings operating cross - border are able to evade paying fines simply by not having a legal presence in some of the territories of member states in which they are active . this reduces incentives to comply with articles 101 and 102 tfeu . the resulting ineffective enforcement distorts competition for law - abiding undertakings and undermines consumer confidence in the internal market , particularly in the digital environment . ### gaps and limitations in ncas ' tools and guarantees undermine the system of parallel powers for the enforcement of articles 101 and 102 tfeu which is designed to work as a cohesive whole based on close cooperation within the european competition network . this system depends on authorities being able to rely on each other to carry out fact - finding measures at each other ' s request . however it does not work well when there are still ncas that do not have adequate fact - finding tools . in other key respects , ncas are not able to provide each other with mutual assistance . for example , in the majority of member states , undertakings operating cross - border are able to evade paying fines simply by not having a legal presence in some of the territories of member states in which they are active . this reduces incentives to comply with articles 101 and 102 tfeu . the resulting ineffective enforcement distorts competition for law - abiding undertakings and undermines consumer confidence in the internal market , particularly in the digital environment .


### member states shall ensure that the maximum amount of the fine a national competition authority may impose on each undertaking or association of undertakings participating in an infringement of articles 101 or 102 tfeu should not be set at a level below 10% of its total worldwide turnover in the business year preceding the decision . ### member states shall ensure that the maximum amount of the fine a national competition authority may impose on each undertaking or association of undertakings participating in an infringement of articles 101 or 102 tfeu is set at 10% of its relevant turnover in the business year preceding the decision .


### the members of the decision - making body of national administrative competition authorities may be dismissed only if they no longer fulfil the conditions required for the performance of their duties or have been guilty of serious misconduct under national law . the grounds for dismissal should be laid down in advance in national law . they shall not be dismissed for reasons related to the proper performance of their duties and exercise of their powers in the application of articles 101 and 102 tfeu as defined in article 5 ; ### the director and the members of the decision - making body of national administrative competition authorities may be dismissed only if they no longer fulfil the conditions required for the performance of their duties or have been found guilty of serious misconduct under national law . the grounds for dismissal should be laid down in advance in national law . they shall not be dismissed for reasons related to the proper performance of their duties and exercise of their powers in the application of articles 101 and 102 tfeu as defined in article 5 of this directive ;


### the exercise of the powers referred to in this directive by national competition authorities shall be subject to appropriate safeguards , including respect of undertakings̕ rights of defence and the right to an effective remedy before a tribunal , in accordance with general principles of union law and the charter of fundamental rights of the european union . ### the exercise of the powers referred to in this directive by national competition authorities shall be consistent with the general principles of union law and the charter of fundamental rights of the european union . in particular , member states shall ensure that the exercise of those powers is subject to appropriate safeguards in respect of undertakings ' rights of defence , such as the right to access the file , the right to be heard , the right to an effective remedy before a tribunal and the right to a fair trial .


### to ensure the independence of ncas , their staff and members of the decision - making body should act with integrity and refrain from any action which is incompatible with the performance of their duties . the need to prevent the independent assessment of staff or members of the decision - making body being jeopardised entails that during their employment and term of office and for a reasonable period thereafter , they should refrain from any incompatible occupation , whether gainful or not . furthermore , this also entails that during their employment and their term of office , they should not have an interest in any businesses or organisations which have dealings with a nca to the extent that this has the potential to compromise their independence . the staff and the members of the decision - making body should declare any interest or asset which might create a conflict of interests in the performance of their duties . they should be required to inform the decision - making body , the other members thereof or , in the case of ncas in which the decision - making power rests with only one person , their appointing authority , if , in the performance of their duties , they are called upon to decide on a matter in which they have an interest which might impair their impartiality . ### to ensure the independence of ncas , their staff , members of the decision - making body and management should act with integrity and refrain from any action which is incompatible with the performance of their duties . the need to prevent the independent assessment of staff , members of the decision - making body and management of ncas being jeopardised entails that during their employment and term of office and for a reasonable period thereafter , they should refrain from any occupation which could give rise to a conflict of interest or be otherwise incompatible , whether gainful or not . furthermore , this also entails that during their employment and their term of office , they should not have an interest in any businesses or organisations which have dealings with a nca to the extent that this has the potential to compromise their independence . the staff , members of the decision - making body and management of ncas should declare any interest or asset which might create a conflict of interests in the performance of their duties . to that end , the staff , members of the decision - making body and management of ncas should make an annual declaration of commitment and declaration of interests , indicating direct or indirect interests that might be considered prejudicial to their independence and might influence their performance . they should be required to inform the decision - making body , the other members thereof or , in the case of ncas in which the decision - making power rests with only one person , their appointing authority , if , in the performance of their duties , they are called upon to decide on a matter in which they have an interest which might impair their impartiality .


### member states shall ensure that current and former employees and directors of applicants for immunity from fines to competition authorities are protected from any criminal and administrative sanctions and from sanctions imposed in non - criminal judicial proceedings for their involvement in the secret cartel covered by the application , if these employees and directors actively cooperate with the competition authorities concerned and the immunity application predates the start of the criminal proceedings . ### member states shall ensure that current and former employees and directors of applicants for immunity from fines to competition authorities are protected from any criminal and administrative sanctions and from sanctions imposed in non - criminal judicial proceedings for their involvement in the secret cartel covered by the application , if these employees and directors actively cooperate with the competition authorities concerned and the immunity application predates the time when the employees and directors were made aware by the competent authorities of the member states of the criminal proceedings .


### member states shall ensure that applicants can apply for leniency in writing and that national competition authorities have a system in place that enables them to accept leniency statements either orally or by other means that do not result in the production of documents , information , or other materials in the applicant’s possession , custody , or control . ### member states shall ensure that applicants can apply for leniency in writing and that national competition authorities have a system in place that enables them to accept leniency statements either orally or by other means that do not result in the production of documents , information , or other materials in the applicant ' s possession , custody , or control . member states shall allow national competition authorities to accept full leniency applications and summary applications in another official language of the union , in addition to the official language or languages of the member state of the national competition authority .


### information collected on the basis of the provisions referred to in this directive should only be used for the purpose for which it was acquired . it should not be used in evidence for the imposition of sanctions on natural persons . ### information collected on the basis of the provisions referred to in this directive should only be used for the purpose for which it was acquired . it should not be used in evidence for the imposition of sanctions on natural persons . where the criminal liability of an individual is concerned , the competition authority may transmit data from the case file to the court or the prosecutor ' s office .


### the exercise of the powers referred to in this directive by national competition authorities shall be subject to appropriate safeguards , including respect of undertakings̕ rights of defence and the right to an effective remedy before a tribunal , in accordance with general principles of union law and the charter of fundamental rights of the european union . ### the exercise of the powers referred to in this directive by national competition authorities shall be subject to appropriate safeguards , including respect of undertakings̕ rights of defence , the right to good administration , the right to a fair trial and the right to an effective remedy before a tribunal , in accordance with general principles of union law and the charter of fundamental rights of the european union .


### where an infringement by an association of undertakings relates to the activities of its members , the maximum amount of the fine shall not be set at a level below 10 % of the sum of the total worldwide turnover of each member active on the market affected by the infringement of the association . however , the financial liability of each undertaking in respect of the payment of the fine shall not exceed the maximum amount set in accordance with paragraph 1 . ### where an infringement by an association of undertakings relates to the activities of its members , the maximum amount of the fine shall not be less than 10 % of the sum of the total worldwide turnover of each member active on the market affected by the infringement of the association . however , the financial liability of each undertaking in respect of the payment of the fine shall not exceed the maximum amount set in accordance with paragraph 1 .


### the requested authority shall not be obliged to enforce decisions pursuant to paragraph 1 if this would be manifestly contrary to public policy in the member state in which enforcement is sought . ### the requested authority shall enforce decisions pursuant to paragraph 1 unless it is able to demonstrate reasonable grounds to the applicant authority showing how this would be manifestly contrary to public policy in the member state in which enforcement is sought .