(1)

The conditions for making fertilisers available on the internal market have been partially harmonised through Regulation (EC) No 2003/2003 of the European Parliament and of the Council (15), which almost exclusively covers fertilisers from mined or chemically produced, inorganic materials. There is also a need to make use of recycled or organic materials for fertilising purposes. Harmonised conditions for making fertilisers made from such recycled or organic materials available on the entire internal market should be established in order to provide an important incentive for their further use. The scope of the harmonisation should therefore be extended in order to include recycled and organic materials.

(1)

The conditions for making fertilisers available on the internal market have been partially harmonised through Regulation (EC) No 2003/2003 of the European Parliament and of the Council (15), which almost exclusively covers fertilisers from mined or chemically produced, mineral materials. There is also a need to make use of recycled or organic materials for fertilising purposes. Harmonised conditions for making fertilisers made from such recycled or organic materials available on the entire internal market should be established in order to provide an important incentive for their further use. Promoting increased use of recycled nutrients would further aid the development of the circular economy and allow a more resource-efficient general use of nutrients, while reducing Union dependency on nutrients from third countries . The scope of the harmonisation should therefore be extended in order to include recycled and organic materials.

(2a)

Nutrients in food originate from the soil; healthy and nutritious soil results in healthy and nutritious crops and food. Farmers need a wide range of fertilisers, organic and synthetic to be available, in order to enhance their soil. When soil nutrients are missing, or depleted, plants will be nutrient deficient and may either stop growing or not contain nutritional value for human consumption.

(5a)

To ensure effective use of animal manure and on-farm compost, farmers should use those products which follow the spirit of ‘responsible agriculture’, favouring local distribution channels, good agronomic and environmental practice and in compliance with the Union environmental law, such as the Nitrates Directive or the Water Framework Directive. The preferential use of fertilisers produced on-site and in neighbouring agricultural undertakings should be encouraged.

(6a)

A CE marked fertilising product might have more than one of the functions described in the product function categories of this Regulation. Where a claim is made in respect of only one of those functions, it should be sufficient for the product to comply with the requirements of the product function category describing that claimed function. By contrast, where a claim is made in respect of more than one of those functions, the CE marked fertilising product in question should be regarded as a combination of two or more component fertilising products, and compliance should be required for each of the component fertilising products with respect to its function. Therefore, there should be a specific product function category to cover such combinations.

(6b)

A manufacturer using one or more CE marked fertilising products that have already been subject to a conformity assessment, carried out by that manufacturer or another manufacturer, might wish to rely on that conformity assessment. For the purpose of reducing the administrative burden to a minimum, the resulting CE marked fertilising product should also be regarded as a combination of two or more component fertilising products, and the additional conformity requirements for the combination should be reduced to the aspects warranted by the mixing.

(8)

Contaminants in CE marked fertilising products, such as cadmium, can potentially pose a risk to human and animal health and the environment as they accumulate in the environment and enter the food chain. Their content should therefore be limited in such products. Furthermore, impurities in CE marked fertilising products derived from bio-waste, in particular polymers but also metal and glass, should be either prevented or limited to the extent technically feasible by detection of such impurities in separately collected bio-waste before processing.

(8)

Contaminants in CE marked fertilising products, if the latter are not used correctly, such as cadmium, can potentially pose a risk to human and animal health and the environment as they accumulate in the environment and enter the food chain. Their content should therefore be limited in such products. Furthermore, impurities in CE marked fertilising products derived from bio-waste, in particular polymers but also metal and glass, should be either prevented or limited to the extent technically feasible by detection of such impurities in separately collected bio-waste before processing.

(8a)

Member States which already have more stringent national limit values for cadmium in fertilisers should be allowed to maintain those limit values until the rest of the Union reaches an equivalent level of ambition.

(8b)

In order to facilitate the compliance of the phosphate fertilising products with the requirements of this Regulation and to boost innovation, it is necessary to provide sufficient incentives for the development of relevant technologies, particularly decadmiation technology, and for the management of cadmium-rich hazardous waste by means of the financial resources available under Horizon 2020, LIFE programmes, the Circular Economy Finance Support Platform, through the European Investment Bank (EIB) and other financial instruments where relevant. The Commission should report annually to the European Parliament and the Council on the incentives and the Union funding provided for decadmiation.

(8c)

As from [date of application of this Regulation] the Commission should establish a mechanism further facilitating access to finance for research and innovation into decadmiation technologies and their implementation in the production process in the Union for all phosphate fertilisers, and into possible cadmium removal solutions that are economically viable on an industrial scale and allow the treatment of the waste generated.

(9)

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 (EC) No 1069/2009 of the European Parliament and of the Council (18), but reaches a point in the manufacturing chain beyond which it no longer poses any significant risk to public or animal health (the ‘end point in the manufacturing chain’), 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 (EC) No 1069/2009 should therefore be amended accordingly.

(9)

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 (EC) No 1069/2009 of the European Parliament and of the Council (18), but has reached a point in the manufacturing chain beyond which it no longer poses a risk to public or animal health (the ‘end point in the manufacturing chain’), 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 (EC) No 1069/2009 should therefore be amended accordingly.

(10)

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 (EC) 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 (EC) 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.

(10)

For each component material category which includes derived products within the meaning of Regulation (EC) 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. To take advantage of technical developments, create more opportunities for producers and businesses, and unlock the potential to make more use of nutrients from animal by-products such as animal manure, the setting of processing methods and recovery rules for animal by-products for which an end-point in the manufacturing chain has been determined should start immediately after the entry into force of this Regulation. When it concerns fertilising products containing or consisting of processed animal manure end-of-livestock-manure criteria should be defined. In order to expand or add component material categories to include more animal by-products, 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. 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 (EC) 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.

(10a)

For animal by-products already widely used in Member States for the production of fertilisers the end point should be determined without undue delay, and at the latest one year after the date of entry into force of this Regulation.

(12)

Where one or more of the component materials for a CE marked fertilising product fall within the scope of Regulation (EC) No 1069/2009 and has not reached the end point in the manufacturing chain , it would be misleading to provide for the product's CE marking under this Regulation , since the making available on the market of such a product is subject to the requirements of Regulation (EC) No 1069/2009. Therefore , such products should be excluded from the scope of this Regulation.

(12)

The making available on the market of an animal by-product or a derived product for which no end point in the manufacturing chain has been defined, or for which the defined end point has not been reached at the time of making available on the market, is subject to the requirements of Regulation (EC) No 1069/2009. Therefore , it would be misleading to provide for the product's CE marking under this Regulation . Any product containing or consisting of such an animal by-product or derived products should therefore be excluded from the scope of this Regulation.

(13)

For certain recovered wastes within the meaning of Directive 2008/98/EC of the European Parliament and of the Council (20), 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.

(13)

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 Council (20) 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 , and accordingly it should be possible for products containing or consisting of such recovered waste materials to access the internal market. To ensure legal clarity, take advantage of technical developments, and further stimulate the incentive among producers to make more use of valuable waste streams, the scientific analyses and the setting of recovery requirements at Union level for such products should start immediately after the entry into force of this Regulation. Accordingly, 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, without unnecessary delay, larger or additional categories of component materials eligible for use in the production of CE marked fertilising products .

(13a)

Certain industry by-products, co-products or recycled products coming from specific industrial processes are currently used by manufacturers as a component of a CE marked fertilising product. For components of CE marked fertilising products, requirements related to component material categories should be laid down in this Regulation. If applicable, 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.

(14)

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.

(14)

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 , safety and environmental 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, safety and environmental criteria. Such substances and mixtures should therefore also be regulated as component materials for CE marked fertilising products.

(14a)

As products made up of substances and mixtures in addition to the fertilising elements are intended to be added to soil and released in to the environment, conformity criteria should apply to all materials in the product, in particular where they are small or break down into small fragments that can be dispersed throughout soil and into water systems and carried to the wider environment. Therefore biodegradability criteria and conformity testing should also be under realistic in-vivo conditions that take into consideration differential rates of decomposition under anaerobic conditions, in aquatic habitats or under water, in waterlogged conditions or in frozen soil.

(15)

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 (EC) No 1107/2009 of the European Parliament and of the Council (21). Regulation (EC) No 1107/2009 should therefore be amended accordingly.

(15)

Certain substances, mixtures and micro-organisms, referred to as plant biostimulants, are not as such inputs of nutrients, but nevertheless stimulate plants' natural nutrition processes. Where such products aim solely at improving the plants' nutrient use efficiency, tolerance to abiotic stress, or crop quality traits, degradation of soil organic compounds, or increasing the availability of nutrients in the rhizosphere , they are by nature more similar to fertilising products than to most categories of plant protection products. Therefore, they act in addition to fertilisers, with the aim of optimising their efficiency and reducing the nutrient application rates . Such products should therefore be eligible for CE marking under this Regulation and excluded from the scope of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (21). Regulation (EC) No 1107/2009 should therefore be amended accordingly.

(15a)

For micro-organisms, component material categories should be expanded or added in order to guarantee and enhance the innovative potential concerning the development and discovery of new microbial plant biostimulant products. In order to stimulate innovation and to create legal certainty for producers concerning the requirements which have to be fulfilled for the use of micro-organisms as component materials for CE marked fertilising products, harmonized methods for the safety evaluation of micro-organisms have to be clearly identified. The preparatory work for defining these safety evaluation methods should start immediately after the entry into force of this Regulation. The power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to define, without any unnecessary delay, the requirements which producers have to comply with when demonstrating the safety of micro-organisms in order to be used in CE marked fertilising products.

(16)

Products with one or more functions, one of which is covered by the scope of Regulation (EC) 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.

(16)

Products with one or more functions, one of which is covered by the scope of Regulation (EC) 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 or the action 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.

(17)

This Regulation should not prevent the application of existing Union legislation relating to aspects of protection of health, safety and the environment not covered by this Regulation. This Regulation should therefore apply without prejudice to Council Directive 86/278/EEC (22), Council Directive 89/391/EEC (23), Regulation (EC) No 1907/2006 of the European Parliament and of the Council (24), Regulation (EC) No 1272/2008 of the European Parliament and of the Council (25), Commission Regulation (EC) No 1881/2006 (26), Council Directive 2000/29/EC (27), Regulation (EU) No 98/2013 of the European Parliament and of the Council (28), and Regulation (EU) No 1143/2014 of the European Parliament and of the Council (29).

(17)

Regardless the type of the CE marked plant nutrition product, this Regulation should not prevent the application of existing Union legislation relating to aspects of protection of health, safety and the environment not covered by this Regulation. This Regulation should therefore apply without prejudice to Council Directive 86/278/EEC (22), Council Directive 89/391/EEC (23), Regulation (EC) No 1907/2006 of the European Parliament and of the Council (24), Regulation (EC) No 1272/2008 of the European Parliament and of the Council (25), Commission Regulation (EC) No 1881/2006 (26), Council Directive 2000/29/EC (27), Regulation (EU) No 98/2013 of the European Parliament and of the Council (28), Regulation (EU) No 1143/2014 of the European Parliament and of the Council (29), Council Directive 91/676/EEC  (29a) , and Directive 2000/60/EC  (29b)

(17a)

The traceability of products which are vulnerable to organic pollution from certain potentially problematic sources (or perceived as such) back to the source of the organic material should be ensured. This is necessary in order to secure consumer confidence and to limit damage if local contamination occurs. As a result, businesses which use fertilising products containing organic material from these sources may be identified. This should be compulsory for products containing material from waste or from by-products which have not undergone any processing that destroys organic pollutants, pathogens and genetic material. The aim is not only to reduce risks to health and the environment but also to reassure public opinion and cater for the concerns of farmers regarding pathogens, organic pollutants and genetic material. In order to protect land owners against pollution for which they themselves are not to blame, Member States are called upon to establish appropriate liability rules.

(17b)

Untreated by-products of animal production should not be subject to this Regulation.

(19a)

In line with the circular economy, certain industry by-products or co-products from specific industrial processes are already used by manufacturers as components of CE marked fertilising products. Requirements related to such component material categories should be laid down in Annex II.

(20)

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 .

(20)

A combination of products from different product function categories , 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 .

(25)

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.

(25)

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 third-country manufacturer, in order to enable market surveillance.

(31)

Where harmonised standards have not been adopted, or do not with sufficient detail cover all elements of the quality and safety requirements laid down in this Regulation, uniform conditions for implementing those requirements may be needed. The Commission should therefore be empowered to adopt implementing acts setting out those conditions in common specifications. For reasons of legal certainty, it should be clarified that CE marked fertilising products must comply with such specifications even if they are considered to be in conformity with harmonised standards.

(31)

Where harmonised standards have not been adopted, or do not with sufficient detail cover all elements of the quality and safety requirements laid down in this Regulation, and where there are undue delays in the process of adopting or updating standards to reflect those requirements , interim measures may be needed to lay down uniform conditions for implementing those requirements . The Commission should therefore be empowered to adopt implementing acts setting out those conditions in common specifications. For reasons of legal certainty, it should be clarified that CE marked fertilising products must comply with such specifications even if they are considered to be in conformity with harmonised standards.

(47)

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.

(47)

CE-marked fertilising products should be placed on the market only if they are sufficiently effective and do not present a risk 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.

(49)

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.

(49)

The existing system should be supplemented by a procedure under which all interested parties , including health and consumers stakeholders, 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.

(55)

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 (EC) 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 .

(55)

Promising technical progress is being made in the field of recycling of waste, such as phosphorus recycling from sewage sludge, such as struvite, fertilising product production from animal by-products, such as biochar , and phosphorus recovery after incineration, such as ash-based products . 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 (EC) No 1069/2009.

(55a)

A CE marked fertilising product may contain other polymers than nutrient polymers, however this should be limited to the cases where the purpose of the polymer is that of controlling the release of nutrients or increasing the water retention capacity of the CE marked fertilising product. It should be possible for innovative products containing such polymers to access the internal market. In order to minimise risks to human health, to safety or to the environment that may be posed by other polymers than nutrient polymers, the criteria for their biodegradation so that they are capable of undergoing physical and biological decomposition should be established. 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 the criteria of the conversion of polymeric carbon to be converted into carbon dioxide (CO2) and a respective testing method for biodegradation.

(56)

Furthermore, it should be possible to react immediately to new findings regarding the conditions for CE marked fertilising products to be sufficiently effective and to new risk assessments regarding human, animal or plant health, safety or the environment. For that purpose, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend the requirements applicable to various categories of CE marked fertilising products.

(56)

Furthermore, it should be possible to react immediately to new findings regarding the conditions for CE marked fertilising products to be sufficiently effective and to new risk assessments regarding human, animal or plant health, safety or the environment , taking into account assessments made by or in cooperation with authorities in the Member States . For that purpose, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend the requirements applicable to various categories of CE marked fertilising products.

(57)

In exercising those powers, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level . The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council .

(57)

When adopting delegated acts provided for in this Regulation, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level , and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts .

(59a)

Due to the high level of dependency on phosphate rock imports in the Union, the Commission has classified that material as a critical raw material. It is therefore necessary to monitor the impact of this Regulation on access to raw material supplies in general, on the availability of phosphate rock in particular, and, in both cases, on prices. After such evaluation, and in the case of negative impact, the Commission should take any measures that it deems to be appropriate in order to remedy those disturbances to trade.

(a)

animal by-products which are subject to the requirements of Regulation (EC) No 1069/2009,

(a)

animal by-products or derived products which are made available on the market subject to the requirements of Regulation (EC) No 1069/2009,

(ba)

Directive 91/676/EEC;

(bb)

Directive 2000/60/EC;

(1)

‘ 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 ;

(1)

‘ plant nutrition 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 nutrient s or of improving their physical or biological growth conditions or their general vigour, yields and quality, including by increasing the ability of the plant to take up nutrients (with the exception of plant protection products covered by Regulation (EC) No 1107/2009) ;

(3)

‘substance’ means a  substance within the meaning of Article 3(1) of Regulation (EC) No 1907/2006 ;

(3)

‘substance’ means a  chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition ;

(13)

‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a CE marked fertilising product;

(13)

‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a CE marked fertilising product or by its production process ;

(b)

fertilising product blends , as specified in product function category 7 in Annex I, containing a fertiliser referred to in point (a).

(b)

combinations from different product function categories , as specified in product function category 7 in Annex I, containing a fertiliser referred to in point (a).

(a)

any refusal, restriction, suspension or withdrawal of a certificate;

(a)

any refusal, restriction, suspension or withdrawal of a certificate or approval decision ;

(b)

shortcomings in the harmonised standards referred to in Article 12 conferring a presumption of conformity.

(b)

shortcomings in the harmonised standards referred to in Article 12;

(ba)

shortcomings in the common specifications referred to in Article 13.

(c)

the EU declaration of conformity does not accompany the CE marked fertilising product ;

(c)

the EU declaration of conformity has not been drawn up ;

(a)

which are likely to be subject of significant trade on the internal market, and

(a)

which have the potential to be subject of significant trade on the internal market, and

(b)

for which there is scientific evidence that the they do not present an unacceptable risk to human, animal or plant health, to safety or to the environment, and that they are sufficiently effective.

(b)

for which there is scientific evidence that the they do not present a risk to human, animal or plant health, to safety or to the environment, and that they are sufficiently effective.

(a)

name of the micro-organism;

(a)

name of the micro-organism at strain level ;

(c)

historical data of safe production and use of the micro-organism

(c)

scientific literature reporting about safe production and use of the micro-organism

(d)

taxonomic relation to micro-organism species fulfilling the requirements for a Qualified Presumption of Safety as established by the European Food Safety Agency ;

(d)

taxonomic relation to micro-organism species fulfilling the requirements for a Qualified Presumption of Safety as established by the European Food Safety Authority, or reference of declared conformity to the relevant harmonised standards on safety of micro-organisms used which have been published in the Official Journal of the European Union, or conformity with the requirements for the safety evaluation of micro-organisms as adopted by the Commission if such harmonised standards are not in place ;

(1a)

‘For derived products falling under the scope of Article 32 that are already widely used in Member States for the production of fertilisers, the Commission shall determine such an end-point by … [six months after the date of entry into force of the Fertilisers Regulation]’.

(3) "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 :

(c)

crop quality traits .

(c)

crop quality.

(ca)

availability of confined nutrients in soil or rhizosphere;

(cb)

degradation of organic compounds in the soil;

(cc)

humification;

(a)

an assessment of the functioning of the internal market for fertilising products, including the conformity assessment and market surveillance effectiveness, an analysis of the effects of partial harmonization on production, use patterns and trade flows of CE marked fertilising products and fertilising products placed on the market under national rules;

(b)

an assessment of application of restrictions on levels of contaminants as laid out in Annex I of this Regulation, any new relevant scientific information as regards the toxicity and carcinogenicity of contaminants if it becomes available, including the risks from uranium contamination in fertilising products;

(c)

an assessment of the developments in decadmiation technologies and their impact, scale and costs across the value chain, as well as related cadmium waste management; and

(d)

an assessment of the impacts on trade in raw material sourcing, including the availability of phosphate rock.

Ca.

Ia.

4.

(a)

Council Regulation (EEC) No 315/93  (32) ,

(b)

Regulation (EC) No 396/2005 of the European Parliament and of the Council  (33) ,

(c)

Regulation (EC) No 470/2009 of the European Parliament and of the Council  (34) or

(d)

Directive 2002/32/EC of the European Parliament and of the Council  (35) ,

4a.

1.

An organic fertiliser shall contain

1.

An organic fertiliser shall contain

—

carbon (C) and

—

organic carbon (Corg) and

—

nutrients

—

nutrients

—

Cadmium (Cd) 1,5 mg/kg dry matter,

—

Cadmium (Cd) 1,0 mg/kg dry matter,

—

Biuret (C2H5N3O2) 12 g/kg dry matter .

—

Biuret (C2H5N3O2) under detection limit .

1a.

2a.

2,5  % by mass of total nitrogen (N), or 2 % by mass of total phosphorus pentoxide (P2O5), or2 % by mass of total potassium oxide (K2O), and

6,5  % by mass of total sum of nutrients.

1a.

2.

The CE marked fertilising product shall contain at least one of the following declared nutrients in the minimum quantities stated:

2.

The CE marked fertilising product shall contain at least one of the following declared primary nutrients in the minimum quantities stated:

—

2 % by mass of total nitrogen (N),

—

1 % by mass of total nitrogen (N), and/or

—

1 % by mass of total phosphorus pentoxide (P2O5), or

—

2 % by mass of total phosphorus pentoxide (P2O5), or

—

2 % by mass of total potassium oxide (K2O).

—

1 % by mass of total potassium oxide (K2O) and

—

6,5  % by mass of total sum of nutrients.

2a.

2 % by mass of total nitrogen (N), or 1 % by mass of total phosphorus pentoxide (P2O5), or2 % by mass of total potassium oxide (K2O), and

5 % by mass of total sum of primary nutrients.

1.

An organo-mineral fertiliser shall be a co-formulation of

1.

An organo-mineral fertiliser shall be a co-formulation of

—

one or more inorganic fertilisers, as specified in PFC 1(C) below, and

—

one or more mineral fertilisers, as specified in PFC 1(C) below, and

—

a material containing organic carbon (C) and

—

one or more materials containing organic carbon (Corg) and

—

nutrients of solely biological origin, excluding material which is fossilized or embedded in geological formations.

—

nutrients of solely biological origin, such as peat, including leonardite, lignite and substances obtained from those materials, but excluding other materials which are fossilized or embedded in geological formations.

—

As of [Publications office, please insert the date occurring three years after the date of application of this Regulation]: 40 mg/kg phosphorus pentoxide (P2O5), and

—

As of [Publications office, please insert the date occurring six years after the date of application of this Regulation]: 40 mg/kg phosphorus pentoxide (P2O5), and

—

As of [Publications office, please insert the date occurring twelve years after the date of application of this Regulation]: 20 mg/kg phosphorus pentoxide (P2O5),

—

As of [Publications office, please insert the date occurring sixteen years after the date of application of this Regulation]: 20 mg/kg phosphorus pentoxide (P2O5),

—

2 % by mass of total phosphorus pentoxide (P2O5), or

—

1 % by mass of Phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate and water , or

2a.

2,5  % by mass of total nitrogen (N), out of which 1 % by mass of the CE marked fertilising product shall be organic nitrogen (N), or2 % by mass of total phosphorus pentoxide (P2O5), or 2 % by mass of total potassium oxide (K2O), and

6,5  % by mass of total sum of primary nutrients.

4.

In the CE marked fertilising product, each unit shall contain the organic matter and the nutrients in their declared content.

4.

In the CE marked fertilising product, each unit shall contain organic carbon and all the nutrients in their declared content. A unit refers to one of the component pieces of product such as granules, pellets, etc.

2a.

and where the sum of the nutrients is minimum 4 %.

3.

Organic carbon (C) shall be present in the CE marked fertilising product by at least 3 % by mass.

3.

Organic carbon (C) shall be present in the CE marked fertilising product by at least 1 % by mass.

1.

An inorganic fertiliser shall be a fertiliser other than an organic or organo-mineral fertiliser .

1.

A mineral fertiliser shall be a fertiliser containing nutrients in a mineral form, or processed into a mineral form from animal or plant origin. Organic carbon (Corg) in the CE marked fertilising product shall not exceed 1 % by mass. That excludes carbon which comes from coatings complying with the requirements of CMC 9 and 10 and agronomic additives complying with the requirements of PFC 5 and CMC 8.

1a.

1b.

1.

An inorganic macronutrient fertiliser shall be aimed at providing plants with one or more of the following macronutrients: nitrogen (N), phosphorus (P), potassium (K), magnesium (Mg), calcium (Ca), sulphur (S) or sodium (Na).

1.

An mineral macronutrient fertiliser shall be aimed at providing plants with one or more of the following macronutrients:

—

As of [Publications office, please insert the date occurring three years after the date of application of this Regulation]: 40 mg/kg phosphorus pentoxide (P2O5), and

—

As of [ six years after the date of application of this Regulation]: 40 mg/kg phosphorus pentoxide (P2O5), and

—

As of [Publications office, please insert the date occurring twelve years after the date of application of this Regulation]: 20 mg/kg phosphorus pentoxide (P2O5),

—

As of [ sixteen years after the date of application of this Regulation]: 20 mg/kg phosphorus pentoxide (P2O5),

1.

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

1.

A straight solid mineral macronutrient fertiliser shall have a declared content of:

(b)

not more than one secondary nutrient (Magnesium (Mg), Calcium (Ca), sulphur (S) and sodium (Na)).

1a.

2.

The CE marked fertilising product shall contain one of the following declared nutrients in the minimum quantity stated:

2.

The CE marked fertilising product shall contain primary and/or secondary declared nutrients in the minimum quantity stated:

—

12 % by mass of total phosphorus pentoxide (P2O5),

—

12 % by mass of phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate and water ,

—

1 % by mass of total sodium oxide (Na2O).

—

3 % by mass of total sodium oxide (Na2O),

1.

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

1.

A compound solid mineral macronutrient fertiliser shall have a declared content of more than one primary and/or secondary nutrient.

2.

The CE marked fertilising product shall contain more than one of the following declared nutrients in the minimum quantities stated:

2.

The CE marked fertilising product shall contain more than one of the primary and/or secondary declared nutrients in the minimum quantities stated:

—

3 % by mass of total phosphorus pentoxide (P2O5),

—

5 % by mass of total phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate and water ,

—

3 % by mass of total potassium oxide (K2O),

—

5 % by mass of total potassium oxide (K2O),

—

1,5  % by mass of total magnesium oxide (MgO),

—

2 % by mass of total magnesium oxide (MgO),

—

1,5  % by mass of total calcium oxide (CaO),

—

2 % by mass of total calcium oxide (CaO),

—

1,5  % by mass of total sulphur trioxide (SO3), or

—

5 % by mass of total sulphur trioxide (SO3),

—

1 % by mass of total sodium oxide (Na2O).

—

3 % by mass of total sodium oxide (Na2O).

—

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.

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

1.

A straight liquid mineral macronutrient fertiliser shall have a declared content of:

(b)

not more than one secondary nutrient.

1a.

2.

The CE marked fertilising product shall contain one of the following declared nutrients in the minimum quantity stated:

2.

The CE marked fertilising product shall contain primary and/or secondary declared nutrients in the minimum quantity stated:

—

5 % by mass of total phosphorus pentoxide (P2O5),

—

5 % by mass of total phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate and water ,

—

5 % by mass of total sulphur trioxide (SO3), or

—

5 % by mass of total sulphur trioxide (SO3),

—

1 % by mass of total sodium oxide (Na2O).

—

from 0,5  % to 5 % by mass of total sodium oxide (Na2O).

1.

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

1.

A compound liquid mineral macronutrient fertiliser shall have a declared content of more than one primary and/or secondary nutrient.

2.

The CE marked fertilising product shall contain more than one of the following declared nutrients in the minimum quantities stated:

2.

The CE marked fertilising product shall contain more than one of the primary and/or secondary declared nutrients in the minimum quantities stated:

—

1,5  % by mass of total nitrogen (N),

—

3 % by mass of total nitrogen (N), or

—

1,5  % by mass of total phosphorus pentoxide (P2O5),

—

1,5  % by mass of total phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate and water ,

—

1,5  % by mass of total potassium oxide (K2O),

—

3 % by mass of total potassium oxide (K2O), or

—

0,75  % by mass of total magnesium oxide (MgO),

—

1,5  % by mass of total magnesium oxide (MgO), or

—

0,75  % by mass of total calcium oxide (CaO),

—

1,5  % by mass of total calcium oxide (CaO), or